BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGAN

    MDR report key: 20639853 · Received November 8, 2024

    Report

    Report Number
    20639853
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RUPTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877175 ALLERGAN PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN SALES, LLC 410FF 2683219

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female