BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO PPP

    MDR report key: 600609 · Received June 25, 2004

    Report

    Report Number
    9617021-2004-00056
    Event Type
    Malfunction
    Date Received
    June 25, 2004
    Date of Event
    May 21, 2004
    Report Date
    May 25, 2004
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS AS A PATIENT WAS BEING LIFTED IN THE SLING, THE STITCHING STARTED TO TEAR. THE PATIENT WAS LOWERED SO THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO PPP PATIENT LIFT FSA ARJO MED AB LTD. KPBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN