BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDEAL IMPLANT STRUCTURED IMPLANT

    MDR report key: 9398747 · Received December 2, 2019

    Report

    Report Number
    3011491947-2019-00274
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 23, 2019
    Report Date
    February 23, 2020
    Manufacturer
    IDEAL IMPLANT INCORPORATED
    Product Code
    FWM
    UDI-DI
    10851795006077
    PMA / PMN Number
    P120011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO MANUFACTURING DEFECT OR OTHER ABNORMALITY WAS FOUND ON MACROSCOPIC OR MICROSCOPIC EXAMINATION OF THE EXPLANTED DEVICE. SURGICAL INSTRUMENT DAMAGE TO THE VALVE WAS OBSERVED DUE TO FTA MISUSE. THE DEVICE WAS NOT IMPLANTED AND THE EVENT IS NOT REPORTABLE. UPDATE AND/OR CORRECTIONS TO THE FOLLOWING SECTIONS: B4, B5, D4, D10, G7, H2, H6, AND H10.

    Description of Event or Problem · 0

    DEFLATION RESULTING IN EXPLANTATION.

    Additional Manufacturer Narrative · 1

    NOT IMPLANTED.

    Description of Event or Problem · 1

    ALLEGED DEFECTIVE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193511 IDEAL IMPLANT STRUCTURED IMPLANT SALINE-FILLED BREAST IMPLANT, FWM IDEAL IMPLANT INCORPORATED 44001 689664 10851795006077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention