Medical Product Safety Information

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The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.</p> <p></p><div class=" panel-group" id="accordion_705460" role="tablist" aria-multiselectable="true"> <div title="Voluntary Reporting For Use by Health Professionals, Consumers, and Patients" open="yes" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67b1d141ab8c5"> <h2 class="panel-title"> <a role="button" data-toggle="collapse" data-parent href="#67b1d141ab8c5" aria-controls="67b1d141ab8c5">Voluntary Reporting For Use by Health Professionals, Consumers, and Patients</a> </h2> </div> <div id="67b1d141ab8c5" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="heading_67b1d141ab8c5"> <div class="panel-body"> <p>Reporting can be done through our <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">online reporting portal</a> or by downloading, completing and then submitting <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="aa243382-bb2e-4c15-a4ca-065b5e640098" href="/media/76299/download?attachment" title="MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)">FDA Form 3500</a> (health professional) or <a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="5396cc92-6482-4f09-a7f4-d2f2fbb0e9c2" href="/media/85598/download?attachment" title="MEDWATCH Consumer Voluntary Reporting (PDF)">3500B</a> (consumer/patient) to MedWatch:The FDA Safety Information and Adverse Event Reporting Program.</p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table class="table table-striped" data-info="false" data-ordering="false" summary="Links to MedWatch forms"> <thead> <tr> <th scope="col" style="width: 50%;">For Use By</th> <th scope="col" style="width: 50%;">Form</th> </tr> </thead> <tbody> <tr> <td> <p><strong>Health Professionals, Patients, and Consumers</strong><br> Easy online, voluntary reporting for health professionals, patients, and consumers.</p> </td> <td><a class="btn btn-primary" href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home">Online Reporting Form</a></td> </tr> <tr> <td> <p><strong>Health Professionals</strong><br> For use by healthcare professionals, consumers, and patients.</p> </td> <td> <p><a href="/media/76299/download">Form FDA 3500 - Voluntary Reporting</a> (pdf)</p> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="774cee16-0ae9-46fa-98f7-f946912ef2a8" href="/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500" title="Instructions for Completing Form FDA 3500">Instructions for Completing Form FDA 3500</a></p> </td> </tr> <tr> <td> <p><strong>Patients and Consumers</strong><br> A consumer-friendly version of the 3500 reporting form.</p> </td> <td><a data-entity-substitution="media_download" 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The FAERS website provides two methods to access the public extract of the FAERS data.  <ul> <li><a href="/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-latest-quarterly-data-files">Quarterly (noncumulative) data files</a> since January 2004 are available for downloading</li> <li><a href="/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard">FAERS Public Dashboard</a> is a highly interactive web-based tool that allows for querying of cumulative FAERS data in a user friendly fashion </li> </ul> </li> <li><a href="http://vaers.hhs.gov/"><strong>Vaccine Adverse Event Reporting System (VAERS)</strong></a><br> VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines.</li> <li><a href="/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude"><strong>Manufacturer and User Facility Device Experience Database (MAUDE)</strong></a><br> Search database information of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. 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