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 3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

 1. Safety


MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
professionals, patients and consumers.

   Report a Problem
   Safety Information
   Stay Informed

MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

 * Prescription and over-the-counter medicines
 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
 * Medical devices such as hearing aids breast pumps, and pacemakers.
 * Combination products such as pre-filled drug syringe, metered-dose inhalers
   and nasal spray.
 * Special nutritional products such as dietary supplements, medical foods and
   infant formulas.
 * Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
 * Food such as beverages and ingredients added to foods.

Other products that the FDA regulates include tobacco products, vaccines, and
animal drugs, devices and food, including pet food. These products utilize
different reporting pathways and it is recommended that reports concerning these
products be submitted directly to the appropriate portals.




Search Showing 1 to 10 of 648 entries


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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 03/21/20222022 Medical Device RecallsMedical
Devices, Radiation-Emitting Products03/21/2022Philips Respironics CPAP, BiPAP,
and Ventilator Recalls: Frequently Asked QuestionsMedical
Devices03/21/2022Philips Respironics Recalls Certain V60 and V60 Plus
Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With
or Without an AlarmMedical Devices03/21/2022Prefilled Saline Flush Syringe
Conservation Strategies - Letter to Health Care PersonnelMedical
Devices03/18/20222022 Safety CommunicationsMedical Devices, Radiation-Emitting
Products03/18/2022Use and Store At-Home COVID-19 Tests Properly to Avoid
Potential Harm: FDA Safety CommunicationMedical Devices03/17/2022Celltrion USA
Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive
Test Results and Unauthorized Shelf LifeMedical Devices03/16/2022Do Not Use SD
Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety CommunicationMedical
Devices03/16/2022SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are
Not Authorized, Cleared, or Approved by the FDA and May Give False
ResultsMedical Devices03/16/2022Stop Using LuSys Laboratories COVID-19 Tests:
FDA Safety Communication Medical Devices

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 * REGULATED PRODUCT(S)
   
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 * MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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    * Medical Product Safety Information
    * Reporting Serious Problems to FDA


MEDWATCH - THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

Your FDA gateway for clinically important safety information and reporting
serious problems with human medical products.

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