BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BCS

    MDR report key: 1821308 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00185
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ZIPPER DAMAGE, TEETH DO NOT ALIGN. RESULTS - EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE PANEL SIDE B WINDOW ZIPPER SLIDER BODY IS OPEN. WINDOW SIDE A HAS 1 INCH ZIPPER DAMAGE ON THE IV PORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CANOPY HAS ZIPPER DAMAGE TO THE RIGHT SIDE PANEL, THE TEETH DO NOT ALIGN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BCS FNL J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI