BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, MUSCLE, PECTORALIS

    MDR report key: 19618352 · Received June 26, 2024

    Report

    Report Number
    3003897287-2024-50002
    Event Type
    Injury
    Date Received
    June 26, 2024
    Manufacturer
    DSAART, LLC
    Product Code
    MIC
    PMA / PMN Number
    KO21337
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT DEVELOPED NECROSIS ON RIGHT PECTORAL ONE MONTH AFTER IMPLANTATION. NO CLEAR CAUSE FOR NECROSIS, BUT INFECTION HAS BEEN RULED OUT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT. PATIENT DIAGNOSED WITH NECROSIS ROUGHLY SIX WEEKS AFTER IMPLANT WAS PLACED. TESTING WAS CONDUCTED ON PATIENT AND RULED OUT ANY PRESENCE OF BACTERIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654628 IMPLANT, MUSCLE, PECTORALIS MIC DSAART, LLC 24-03-009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown