BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3123260 · Received May 21, 2013

    Report

    Report Number
    3004493922-2013-01110
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 26, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A 350 OR 440 RELIANT LIFT, WHERE THE R130 SLING IS TOO BIG FOR THE USER, AND IT IS TIGHT UNDERNEATH THE ARMS AND IS CAUSING DISCOMFORT, SORENESS, AND TENDERNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224443 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU UNKNOWN RELIANT 350 OR 440 LIFT; R130 SLING

    Patients

    Seq Age Sex Outcome Treatment
    1 66 Other