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href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p><a class="btn btn-default btn-sm" data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="73a337e5-ef3e-4826-8e37-bf689a3a808e" href="/safety/reporting-serious-problems-fda/product-problems" title="Product Problems">English</a></p> <p>Los problemas con los productos deben reportarse a la Administraci贸n de Alimentos y Medicamentos de los Estados Unidos (FDA, por su sigla en ingl茅s) cuando existan dudas en cuanto a su calidad, autenticidad, resultados o inocuidad de cualquier medicamento o dispositivo. Pueden surgir problemas con la calidad del producto durante la fabricaci贸n, el env铆o o el almacenamiento. Entre estos problemas se incluyen: </p> <div data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="medium" data-entity-type="media" data-entity-uuid="cecceb45-9e28-4f4f-b642-8d202b9bd762" title="Nurse holding a computer" class="align-right embedded-entity" data-langcode="en"> <img loading="lazy" src="/files/styles/medium/public/nurse_holding_a_computer.jpg?itok=iBTHAXN1" alt="Nurse holding a computer" title="Nurse holding a computer" class="img-responsive"> </div> <ul> <li>presunta falsificaci贸n de productos</li> <li>contaminaci贸n del producto</li> <li>componentes defectuosos</li> <li>embalaje deficiente o mezcla de productos</li> <li>estabilidad dudosa</li> <li>mal funcionamiento del dispositivo</li> <li>inquietudes con relaci贸n al etiquetado</li> </ul> <p>En cuanto a los medicamentos, un farmac茅utico suele ser el primero en reconocer un problema de calidad del producto. Por lo general, las enfermeras son las primeras en reconocer un problema con un dispositivo m茅dico. Informe estas sospechas a la FDA a trav茅s de MedWatch.</p> <h2>Ejemplos</h2> <ul> <li>Un m茅dico inform贸 al farmac茅utico del hospital que sospechaba que la epoetina alfa administrada a un paciente podr铆a ser una falsificaci贸n debido a una reacci贸n inusual en el lugar de la inyecci贸n. El farmac茅utico, despu茅s de inspeccionar el vial, la etiqueta y el embalaje, not贸 diferencias en la calidad del embalaje entre la muestra sospechosa y otros lotes. Se present贸 un informe de MedWatch a la FDA. Investigaciones posteriores determinaron que el producto era falsificado y estaba contaminado con bacterias.</li> <li>Un cliente volvi贸 a la farmacia despu茅s de comprar una botella de un anti谩cido l铆quido y se quej贸 del mal olor que emanaba del producto al abrirlo. El farmac茅utico tom贸 nota del terrible olor y tambi茅n observ贸 que el envase de pl谩stico estaba hinchado. El cliente recibi贸 un producto similar para reemplazar este anti谩cido. A continuaci贸n, el farmac茅utico revis贸 las existencias en el almac茅n y los n煤meros de lote del producto afectado. Luego se contact贸 a la FDA para transmitir esta inquietud sobre la calidad del producto farmac茅utico y proporcionar los datos necesarios para investigar este lote de producci贸n.</li> <li>Mientras almacenaba una caja de frascos de 15 cc de jarabe de ipecacuana, un t茅cnico de farmacia not贸 que una botella semitransparente etiquetada como jarabe de ipecacuana ten铆a un color mucho m谩s claro que el resto. Se contact贸 inmediatamente a la FDA a trav茅s de su programa de informes voluntarios. En un d铆a se estaba llevando a cabo una investigaci贸n. Se descubri贸 que el producto transl煤cido no era jarabe de ipecacuana sino otro agente que, si bien no era t贸xico, no producir铆a el efecto deseado de dicho jarabe si se usaba para tratar un caso de intoxicaci贸n. Como resultado de la investigaci贸n, el producto fue retirado del mercado debido a esta confusi贸n en el etiquetado.</li> <li>Un farmac茅utico escuch贸 un ruido al agitar un frasco de 5 cc de jarabe de difenhidramina. Despu茅s de quitar el sello, se evidenci贸 que el ruido era causado por pedazos de vidrio sueltos que flotaban en el jarabe. Reconociendo la naturaleza potencialmente mortal de este producto si se ingiere, se contact贸 a la FDA. Un investigador de la FDA recogi贸 las muestras e inici贸 una investigaci贸n en el lugar de fabricaci贸n. Los resultados revelaron un problema con la producci贸n de botellas de vidrio. Como resultado de este informe, el producto fue retirado del mercado a nivel nacional.</li> <li>Una enfermera not贸 un cable deshilachado que conduc铆a al colgante (control manual) de una cama de hospital. Una investigaci贸n mostr贸 que el cableado estaba defectuoso y ten铆a tendencia a deshilacharse en su punto de entrada a la carcasa del colgante. Esto presentaba un peligro potencial de descarga el茅ctrica e incendio. Una recomendaci贸n de retiro del mercado afect贸 a 33,155 colgantes en distribuci贸n.</li> </ul> <h2>Recursos</h2> <ul> <li><a href="https://www.accessdata.fda.gov/scripts/email/oc/buyonline/spanish.cfm">Reporte ventas ilegales de productos m茅dicos a trav茅s de Internet</a></li> <li><a href="https://www.accessdata.fda.gov/scripts/email/oc/oci/contactSpanish.cfm">Reporte Actividad Criminal Sospechosa </a></li> <li><a href="https://www.safetyreporting.hhs.gov/SRP2/es/Home.aspx?sid=d9b31098-ecec-4b18-b9ae-87c538d49f2e">Reporte problemas con suplementos nutricionales y productos de tabaco en l铆nea</a></li> <li><a href="https://vaers.hhs.gov/indexSpanish.html">Problemas con las vacunas - VAERS</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b052f4ba-c5fa-43a9-8f00-e2827dfb7169" href="/animal-veterinary/report-problem/reportar-un-problema" title="Reporta un problema">Reporte un problema con un animal o producto veterinario</a></li> <li><a href="https://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm" target>Contacte a su coordinador de quejas del consumidor local </a></li> </ul> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> <!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET--> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-05-01T00:00:00Z">05/01/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Biologics</li> <li role="menuitem">Dietary Supplements</li> <li role="menuitem">Drugs</li> <li role="menuitem">Medical Devices</li> <li role="menuitem">Radiation-Emitting Products</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/fda-en-espanol/reporte-problemas-serios-la-fda" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Reporte problemas serios a la FDA </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-350a62d1885ddb936f3eee21d4cbf90ad1516ae7a1eb86fd97fc5b6c9b1c627d"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/fda-en-espanol/reporte-problemas-serios-la-fda/problemas-con-los-productos-que-regula-la-fda" class="lcds-section-nav__link lcds-section-nav--side__link">Problemas con los productos que regula la FDA</a></li> <li><a href="/fda-en-espanol/reporte-problemas-serios-la-fda/que-es-una-reaccion-adversa-grave" class="lcds-section-nav__link lcds-section-nav--side__link">驴Qu茅 es una reacci贸n adversa grave?</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-5e0a69979498fc84db5ce7b01c78dc57b3bfa567ec63e5a19a1cf3751935b8fe"> </div> </div> </li> </ul> 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