BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED CANOPY SYSTEM

    MDR report key: 1872147 · Received October 12, 2010

    Report

    Report Number
    2020362-2010-00279
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    September 14, 2010
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ZIPPER DAMAGE, BROKEN TEETH EVAL: RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE PANEL SIDE B: WINDOW ZIPPER SLIDER BODY IS OPEN; THE DRAINAGE PORT HAS 2 INCHES OF BROKEN STITCHES AT START AND END OF ZIPPER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THERE'S ZIPPER DAMAGE TO THE RIGHT SIDE PANEL THAT TEETH ARE BROKEN. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED CANOPY SYSTEM FNL J. T. POSEY COMPANY 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI