BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BCS ACUTE CARE, LTC

    MDR report key: 1821309 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00186
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ZIPPER DAMAGE. RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE PANEL SIDE A ZIPPER SLIDER BODY IS OPEN. PANEL A HAS THREE INCH TEAR IN THE MATERIAL AT THE START OF THE DRAINAGE PORT. PANEL B HAS SIX INCH TEAR IN THE MATERIAL AT THE START OF THE DRAINAGE PORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CANOPY HAS A ZIPPER THAT IS DAMAGED ON THE SIDE PANEL, BUT COULDN'T SPECIFY WHAT TYPE OF DAMAGE. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION SHOWS THAT THE PANEL SIDE A SLIDER BODY IS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BCS ACUTE CARE, LTC FNL J. T. POSEY CO. 8050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI