BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDICARE

    MDR report key: 10036475 · Received May 7, 2020

    Report

    Report Number
    3007802293-2020-00006
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Report Date
    May 7, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DEALER NOTED THAT THE ARM OF THE INDEPENDENT LIFTER (RIGID BODY-SUPPORT UNIT) WAS CRACKED AND NOTIFIED HANDICARE. THERE WAS NO IMPACT TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497960 HANDICARE INDEPENDENT LIFTER FSA HANDICARE USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1