BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLL GUARD

    MDR report key: 1242543 · Received November 21, 2008

    Report

    Report Number
    2020362-2008-00012
    Event Type
    Other
    Date Received
    November 21, 2008
    Report Date
    October 23, 2008
    Manufacturer
    POSEY CO.
    Product Code
    FNJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER): - NO MALFUNCTION OF THE PRODUCT. EVALUATION CONCLUSIONS: (OTHER) - NO REPORTED MALFUNCTION OF THE DEVICE. THE PRODUCT HAS NOT YET BEEN RECEIVED BY POSEY CO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S FAMILY PURCHASED A ROLL GUARD AND APPLIED IT TO THEIR MOTHER'S STANDARD TWIN SIZE BED AT HER LONG TERM CARE FACILITY AGAINST THEIR RECOMMENDATIONS. THE FAMILY INSISTED ON USING IT ON THE TWIN BED, THE STRAPS WOULD ONLY BE TUCKED UNDER THE MATTRESS. THE PATIENT REMOVED THE ROLL GUARD AND ATTEMPTED TO GET OUT OF THE BED, AND SHE FELL. THE MOTHER WAS TAKEN TO THE HOSPITAL FOR OBSERVATION AND NO INJURY OCCURRED. THE FAMILY ADMITTED TO THEIR ERROR IN APPLYING THIS PRODUCT TO THEIR MOTHER AND THAT IT WAS NO FAULT OF THE ROLL GUARD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLL GUARD FNJ POSEY CO. 5700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization