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Medical Device Reporting

Medical Device Reporting

For more information, please contact The Ahearne Law Firm, PLLC for an initial consultation and case evaluation. Call nationwide at (845) 986-2777.

Each year, the United States Food & Drug Administration (FDA) receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Device User Facilities: A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using Medwatch, the FDA Safety Information and Adverse Event Reporting Program.

Patients, healthcare professionals, caregivers and consumers who find a problem related to a medical device are encouraged to voluntarily report medical device adverse events, product use errors, product quality problems and side effects to the FDA through MedWatch. MedWatch may also be used for:

  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
  • Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
  • Combination products
  • Special nutritional products (infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

Defective orthopedic medical devices such as hip, knee and shoulder implants are often recalled, forcing many patients to undergo revision surgery to replace the implant and repair damaged bone and tissue surrounding the initial implant. Frequently, patients will file lawsuits against the manufacturers of these medical devices, such as Zimmer Biomet, Stryker, Smith and Nephew, Medtronic, Corin, Nuvasive, Depuy Synthes/Johnson & Johnson, Orthosensor, Integra Lifescience, Globus Medical, B.Braun Melsungen AG, Waldemar LINK GmbH & Co. KG, Exactech, Tornier and DJO. For instance, thousands of lawsuits are pending in state and federal courts across the United States against hip implant manufacturers given the notorious failure of metal-on-metal hip implants. The U.S. Food and Drug Administration (FDA) cleared metal-on-metal hip implants through its expedited 510(k) process that permits devices onto the market without substantial clinical testing for safety or efficacy. Although metal-on-metal hip implants are designated high-risk, manufacturers were able to clear them through 510(k) due to a loophole that temporarily permitted such products through this route.

#FDA #hip #knee #shoulder #implant #medicaldevice

If you or a family member have had hip, knee or shoulder replacement surgery, or have had revision surgery to remove and replace a hip, knee or shoulder implant, you and/or your family member may be entitled to money damages.

For more information, please contact The Ahearne Law Firm, PLLC for an initial consultation and case evaluation. Call nationwide at (845) 986-2777.

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