BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDEAL IMPLANT STRUCTURED BREAST IMPLANT

    MDR report key: 8765860 · Received July 6, 2019

    Report

    Report Number
    3011491947-2019-00164
    Event Type
    Malfunction
    Date Received
    July 6, 2019
    Date of Event
    April 11, 2019
    Report Date
    July 6, 2019
    Manufacturer
    IDEAL IMPLANT
    Product Code
    FWM
    UDI-DI
    10851795006015
    PMA / PMN Number
    P120011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT ANALYSIS SHOWED SILICONE DEBRIS IN THE POSTERIOR VALVE CHANNEL, AFFECTING SEAL OF THE VALVE AND CAUSING LEAK.

    Description of Event or Problem · 1

    DEFLATION RESULTING IN EXPLANTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559569 IDEAL IMPLANT STRUCTURED BREAST IMPLANT SALINE-FILLED BREAST IMPLANT FWM IDEAL IMPLANT 24001 665071 10851795006015

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention