BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BED

    MDR report key: 3810657 · Received March 24, 2014

    Report

    Report Number
    2020362-2014-00096
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Report Date
    February 27, 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

    EVALUATION OF THE PRODUCT CONFIRMED THE REPORTED ISSUE: THE LEFT SIDE WINDOW ZIPPER IS MISSING ONE ELEMENT (TOOTH) ON THE ZIPPER TRACK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PUSHED A ZIPPER TEETH LOOSE ON THE LEFT SIDE PANEL. CUSTOMER ALSO REPORTED THAT A TOOTH ON THE LEFT PANEL IS MISSING ON ONE SECTION. CUSTOMER DID NOT PROVIDE THE DATE WHEN THE INCIDENT OCCURRED BUT DID PROVIDE THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172782 POSEY BED OYS J. T. POSEY CO. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK