BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARJO STYLE SLING

    MDR report key: 2171916 · Received February 16, 2007

    Report

    Report Number
    9615246-2007-00002
    Event Type
    Other
    Date Received
    February 16, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 5, 2007
    Manufacturer
    T.H.E. MEDICAL
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOP WAS (B)(6) 2003. SLING INSPECTION INSTRUCTIONS ACCOMPANY THE PRODUCT. PICTURES VIEWED OF CONDITION OF SLING SHOWS THAT IT IS BEING USED WELL PAST ACCEPTABLE LIMITS.

    Description of Event or Problem · 1

    PLASTIC RETAINING CLIP ON SLING BROKE. PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO STYLE SLING SLING FOR PATIENT LIFTER FNG T.H.E. MEDICAL TA404BLM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other