BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DISPOSABLE SLING

    MDR report key: 10024067 · Received May 5, 2020

    Report

    Report Number
    10024067
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 23, 2020
    Report Date
    April 30, 2020
    Manufacturer
    HANDICARE USA INC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SLING IS MISSING ONE OF THE STRAPS THAT ATTACHES TO LIFT. IF PATIENT LIFTED WITHOUT ALL 6 STRAPS SECURED, PATIENT COULD POTENTIALLY FALL OUT OF LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490307 UNIVERSAL DISPOSABLE SLING NON-AC-POWERED PATIENT LIFT FSA HANDICARE USA INC 547060MX120220

    Patients

    Seq Age Sex Outcome Treatment
    1