BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3881056 · Received April 8, 2014

    Report

    Report Number
    2020362-2014-00129
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    February 28, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K113355
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND AN OPEN SLIDER BODY ON THE PATIENT ACCESS AND THE MATTRESS ENVELOPE DELAMINATED ON PANEL SIDE A. THE ELASTIC ON PANEL SIDE D IS ALSO TORN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ZIPPER DAMAGE ON PANEL SIDE B. CUSTOMER DID NOT PROVIDE A DATE WHEN ISSUE WAS DISCOVERED. NO PATIENT INCIDET OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211822 POSEY BED OYS OYS J. T. POSEY CO. 8060 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK