BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROMEDIC

    MDR report key: 2935259 · Received January 25, 2013

    Report

    Report Number
    3005536958-2013-00001
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 15, 2013
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE (B)(6)'S BEGAN TO LIFT A RESIDENT ON THE BED, A SLING LOOP CAME LOOSE FROM THE SLING. THE SLING FELL DOWN ONTO THE MATTRESS WITH THE PT REMAINING IN THE SLING. RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36263 ROMEDIC SHELL HIGH BACK SLING XS FSA HANDICARE AB 40700003 2009-07-G 6950

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other