BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3823733 · Received February 20, 2014

    Report

    Report Number
    2020362-2014-00055
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    OYS
    PMA / PMN Number
    K103817
    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 DID NOT CONFIRM THE REPORTED ISSUE. THE ZIPPER SLIDER BODY IS OPEN ON THE LEFT PATIENT ACCESS WINDOW. RIGHT SIDE WINDOW ZIPPER PULL TAB IS MISSING AND THERE ARE BROKEN STITCHES ON THE TOP RIDGE. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE RIGHT SIDE RETAINING BOX IS MISSING AND THE TEETH AND INSERT PIN IS DAMAGED. THIS WAS DISCOVERED DURING SETUP IN THEIR WAREHOUSE AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106568 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA