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frameborder="0" height="315" src="https://www.youtube.com/embed/bsr3XZ5hRLo"> </iframe> </div> </div> <hr> <p><a class="btn btn-default btn-sm" data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="30cfb1be-3244-4fd7-a804-9647e3551562" href="/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda" title="Reporting Serious Problems to FDA">English</a></p> <p>La FDA regula una amplia variedad de productos, que incluyen medicamentos para personas y animales, productos biol贸gicos, dispositivos m茅dicos, suplementos diet茅ticos, f贸rmulas infantiles y productos cosm茅ticos. Los consumidores pueden reportar efectos secundarios inesperados, eventos adversos u otros problemas con productos regulados a trav茅s del programa MedWatch de la FDA.</p> <a href="/media/122470/download"> <div alt="MedWatch Form SPAN 2023.jpg" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="Array" data-entity-type="media" data-entity-uuid="e30104f6-b218-44b4-a2ff-908d2a1f1eaa" data-langcode="en" title="MedWatch Form SPAN 2023.jpg" class="align-right embedded-entity"> <img loading="lazy" src="/files/MedWatch%20Form%20SPAN%202023_0.jpg" alt="MedWatch Form SPAN 2023.jpg" title="MedWatch Form SPAN 2023.jpg" class="img-responsive"> </div> </a> <p> </p> <p> </p> <p>MedWatch es el programa de la Administraci贸n de Alimentos y Medicamentos (FDA, por su sigla en ingl茅s) para reportar <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2f636895-9875-4c8f-9e58-1f564749b660" href="/safety/reporting-serious-problems-fda/que-es-una-reaccion-adversa-grave" title="驴Qu茅 es una reacci贸n adversa grave?">reacciones graves</a> y p<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7fef5b7f-4e32-450e-9836-cc88d375641c" href="/safety/reporting-serious-problems-fda/problemas-con-los-productos" title="Problemas con los productos">roblemas de calidad de los productos</a>, inequivalencia o fallas terap茅uticas y errores con el uso de los productos m茅dicos para humanos, incluyendo medicamentos, productos biol贸gicos, aparatos m茅dicos, suplementos diet茅ticos, f贸rmula para beb茅s y cosm茅ticos.</p> <p>Si cree que usted o alguien en su familia ha experimentado una reacci贸n grave a un producto m茅dico, le recomendamos que lleve el formulario de reporte a su m茅dico. Su proveedor de cuidado m茅dico puede ofrecerle informaci贸n cl铆nica bas谩ndose en su expediente m茅dico que puede ayudar a la FDA a evaluar su reporte.</p> <p>No obstante, entendemos que debido a una serie de razones, es posible que usted no desee que su proveedor de atenci贸n m茅dica llene el formulario, o su proveedor de atenci贸n m茅dica pudiera decidir no llenar el formulario. Su proveedor de atenci贸n m茅dica NO tiene la obligaci贸n de hacer un reporte a la FDA. En estas situaciones, usted s贸lo puede llenar el Formulario de Reporte.</p> <p>Usted recibir谩 un acuso de recibo cuando la FDA reciba su reporte. El personal de la FDA revisa los reportes. Se le contactar谩 personalmente solamente si necesitamos informaci贸n adicional.</p> <h2>Los consumidores, pacientes y profesionales de la salud pueden hacer un reporte voluntariamente</h2> <p>Para mantener los productos m茅dicos efectivos disponibles en el mercado, la FDA se basa en la notificaci贸n voluntaria de estos eventos. La FDA utiliza estos datos para mantener nuestra vigilancia de seguridad de estos productos. Su reporte puede ser la acci贸n cr铆tica que provoque una modificaci贸n en el uso o dise帽o del producto, mejore su seguridad y conduzca a una mayor seguridad del paciente.</p> <p>Si el enlace al formulario de reporte voluntario en PDF (a continuaci贸n) no abre autom谩ticamente el formulario en su navegador, intente instalar la 煤ltima versi贸n gratuita de Adobe Acrobat Reader.</p> <h2>C贸mo hacer un reporte de un evento adverso o una reacci贸n grave a la FDA</h2> <p>Use uno de los m茅todos de abajo para reportar eventos adversos a la FDA</p> <ol> <li><a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">Haga un reporte en l铆nea</a> (s贸lo en ingl茅s).</li> <li><a href="/media/122470/download">Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (Baje el formulario en espa帽ol)</a>. <ul> <li><a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.spanish">Suba el documento en l铆nea</a>, </li> <li>Siga las instrucciones en el formulario para mandarlo por correo o fax.</li> <li>Vea el video de arriba sobre c贸mo llenar el formulario.</li> </ul> </li> <li><b>Llame a la FDA al 1-800-FDA-1088</b> (1-800-332-1088) para hacer un reporte por tel茅fono.</li> <li>Formulario de Reportes FDA 3500 com煤nmente utilizado por los profesionales de la salud. <span><span><a href="/safety/download-forms/instructions-completing-form-fda-3500" target>Consulte las instrucciones para el Formulario FDA 3500</a></span></span> (en ingl茅s). </li> </ol> <hr> <h2>Art铆culos sobre c贸mo reportar problemas a la FDA</h2> <ul> <li><a href="/consumers/articulos-en-espanol/como-denunciar-problemas-con-los-productos-y-presentar-quejas-ante-la-fda">C贸mo denunciar problemas con los productos y presentar quejas ante la FDA </a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a279a8a6-f513-4d63-9420-204f694d795e" 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