BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDEPENDENT LIFTER - SMALL

    MDR report key: 10820037 · Received November 10, 2020

    Report

    Report Number
    3007802293-2020-00020
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 10, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED AND RECEIVED FOR INVESTIGATION. WHEN COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WE ARE STILL AWAITING DETAILS FROM THE CUSTOMER. THUS FAR, THE DEALER HAS ONLY REPORTED THAT THE INDEPENDENT LIFTER TWISTED DURING USE, CAUSING THE USER TO FALL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281006 INDEPENDENT LIFTER - SMALL INDEPENDENT LIFTER FSA HANDICARE USA INC. 341600

    Patients

    Seq Age Sex Outcome Treatment
    1