BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY

    MDR report key: 1950908 · Received November 3, 2010

    Report

    Report Number
    2020362-2010-00331
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    October 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVAL FOR THE RETURNED PRODUCT SHOWS THAT THE PANEL SIDE A & B ZIPPER SLIDER BODIES ARE OPEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ZIPPER ON THE MAIN ACCESS PANEL DOES NOT CLOSE PROPERLY WHEN THEY TRY TO ZIP IT UP. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI