BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDEAL IMPLANT STRUCTURED BREAST IMPLANT

    MDR report key: 11668405 · Received April 14, 2021

    Report

    Report Number
    3011491947-2021-00085
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 3, 2021
    Manufacturer
    IDEAL IMPLANT INCORPORATED
    Product Code
    FWM
    UDI-DI
    10851795006138
    PMA / PMN Number
    P120011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEFLATION OF THE OUTER LUMEN DUE TO A TEAR AT THE DOME OF THE OUTER SHELL. THERE WAS NO EVIDENCE OF FATIGUE OR INSTRUMENT DAMAGE, SO THE CAUSE OF THIS TEAR COULD NOT BE DETERMINED. NO OTHER DEFECTS WERE FOUND ON MACROSCOPIC OR MICROSCOPIC ANALYSIS OF THE IMPLANT.UPDATE/CORRECTION TO SECTIONS B1, B2, B4, B5, D6B, D9, G3, G6, H2, H3, H6 AND H10.

    Description of Event or Problem · 0

    DEFLATION RESULTING IN EXPLANTATION.

    Description of Event or Problem · 1

    ALLEGED DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560597 IDEAL IMPLANT STRUCTURED BREAST IMPLANT SALINE-FILLED BREAST IMPLANT FWM IDEAL IMPLANT INCORPORATED 67501 61936 10851795006138

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention