BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 11655185 · Received April 13, 2021

    Report

    Report Number
    3012316249-2021-00017
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IMG
    PMA / PMN Number
    K032941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONNECTOR IS MISSING (BROKEN OFF). PLASTIC CASING IS MISSING, BLUE WIRE THAT CONNECTS TO WHITE END HAS A PIECE OF WIRE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552549 RICHMAR APPLICATOR HAMMER IMG COMPASS HEALTH BRANDS 410-115

    Patients

    Seq Age Sex Outcome Treatment
    1