BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY STAYSAFE BED

    MDR report key: 2123375 · Received June 10, 2011

    Report

    Report Number
    2020362-2011-00195
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    May 18, 2011
    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) - ZIPPER TEETH WILL NOT ALIGN. RESULTS: EVAL OF THE PRODUCT FOUND THE ON PANEL SIDE B, THE PT ACCESS WINDOW ZIPPER SLIDER BODY IS OPEN. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE TEETH WILL NOT ALIGN WHEN AN ATTEMPT IS MADE TO ZIP THE RIGHT SIDE PANEL. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI