BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE, SMOOTH ROUND HIGH GEL BREAST IMPLANT (RIGHT BREAST)

    MDR report key: 18989999 · Received March 27, 2024

    Report

    Report Number
    MW5153277
    Event Type
    Injury
    Date Received
    March 27, 2024
    Report Date
    March 27, 2024
    Manufacturer
    MENTOR WORLDWIDE, LLC / MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS SHOWN IN THE FORWARDED COMMUNICATION, I HAVE SENT MY REQUEST FOR CONSIDERATION, ADDITIONAL RESEARCH AND INVESTIGATION INTO MENTOR WORLDWIDE, LLC ¿S LIABILITY FOR THE DOZENS OF WORSENING IDENTICAL HEALTH CONDITIONS OF HUNDREDS OF WOMEN WHOM HAVE RECEIVED THEIR SILICONE, SMOOTH ROUND HIGH GEL BREAST IMPLANTS. REFERENCE REPORT: MW5153276.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721345 SILICONE, SMOOTH ROUND HIGH GEL BREAST IMPLANT (RIGHT BREAST) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE, LLC / MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown