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 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 694 entries


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Product Type Biologics Drugs Medical Devices
Year 202220212020201920182017
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DateSafety AlertProduct Type 06/07/2022Buzzagogo, Inc. Issues Voluntary
Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to
Potential Microbial ContaminationDrugs, Potential Foreign Material06/03/20222022
Medical Device RecallsMedical Devices, Radiation-Emitting Products06/03/2022FAQs
on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine
RecallsMedical Devices06/03/2022Philips Respironics Recalls All V60 and V60 Plus
Ventilators for Power Issue that May Cause Ventilator to Stop with or without
Alarms06/02/20222022 Safety CommunicationsMedical Devices, Radiation-Emitting
Products06/02/2022Atrium Medical Corporation Recalls iCast Covered Stent for
Potential Balloon or Catheter Hub Separation That May Cause Patient HarmMedical
Devices06/02/2022Baxter Issues Urgent Medical Device Correction to Reinforce
Important Safety Information Regarding Possible Risk of Oxygen Desaturation
While Using Volara Device in Line With Ventilator in a Home Care
EnvironmentDefect, Medical Devices06/02/2022FDA Warns Against Use of
Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety
CommunicationMedical Devices06/02/2022Illumina Cybersecurity Vulnerability May
Present Risks for Patient Results and Customer Networks: Letter to Health Care
ProvidersMedical Devices06/02/2022UPDATE: FDA Updates Recommendations for the
Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety
Communication Medical Devices

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MEDWATCH - THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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serious problems with human medical products.

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