BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3955481 · Received July 24, 2014

    Report

    Report Number
    9616091-2014-01293
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END USER, THE SLING CUT HER LEG AND CREATED A BOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433752 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 Other