BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C300

    MDR report key: 11098675 · Received December 30, 2020

    Report

    Report Number
    3007802293-2020-00027
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 30, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THIS UNIT TO BE RETURNED SO AN INVESTIGATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    THE USER WAS TRANSFERRING HIS SON FROM A CHAIR TO A BED. WHEN LOWERING, THE STRAP BROKE ABOUT 1 FOOT ABOVE THE BED. THE INDIVIDUAL WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561341 C300 PATIENT LIFT FSA HANDICARE USA INC. 330057

    Patients

    Seq Age Sex Outcome Treatment
    1