BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSEY BED ALL-IN-ONE SYSTEM

    MDR report key: 1546766 · Received November 24, 2009

    Report

    Report Number
    2020362-2009-00699
    Event Type
    Other
    Date Received
    November 24, 2009
    Report Date
    October 25, 2009
    Manufacturer
    POSEY, S. DE R. L. DE C. V.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE MESH NETTING ON THE LEFT WINDOW HAS A TWO FOOT TEAR. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE PATIENT HAD A PLASTIC KNIFE AND HAD CUT THE NETTING ON THE SIDE PANEL WINDOW. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED ALL-IN-ONE SYSTEM FNL POSEY, S. DE R. L. DE C. V. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI