BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHMAR

    MDR report key: 11812483 · Received May 12, 2021

    Report

    Report Number
    3012316249-2021-00018
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 12, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    IMG
    PMA / PMN Number
    K032941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE APPLICATOR DOESN'T WORK BUT IT MAKES A TICKING NOISE WHEN ON. THE MACHINE CONNECTOR POINT NEEDS REPLACEMENT ON THE CORD. PER PICTURES, FISCHER CONNECTOR IS BROKEN, WIRES ARE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710451 RICHMAR APPLICATOR AUTOSOUND IMG COMPASS HEALTH BRANDS 410-200

    Patients

    Seq Age Sex Outcome Treatment
    1