BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 11435066 · Received March 8, 2021

    Report

    Report Number
    3012316249-2021-00009
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    March 8, 2021
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    ILS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE NEED REPLACEMENT PARTS FOR A CAREX COMMODE ASSIST PURCHASED FROM (B)(6) LESS THAN A YEAR AGO ON (B)(6) 2020. WE NEED THE MECHANISM THAT BOLTS TO THE LOCK RELEASE LEVER. THE METAL HAS FATIGUED AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332606 COMPASS HEALTH BRANDS UPLIFT COMMODE ASSIST ILS COMPASS HEALTH BRANDS CCFCA200

    Patients

    Seq Age Sex Outcome Treatment
    1