BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK RELEASE LIMB HOLDERS

    MDR report key: 3820862 · Received April 15, 2014

    Report

    Report Number
    2020362-2014-00132
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 13, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT WAS NOT MAINTAINED BY THE FACILITY AND DISCARDED. NOTE: THE CUSTOMER STATED THAT THE PRODUCT WAS DISCARDED BECAUSE THE STAFF FELT THERE WAS NO ISSUE WITH THE PRODUCT. THE STAFF HAD PREVIOUSLY CONCLUDED THAT A STAFF EDUCATIONAL ISSUE LED TO THE REPORTED PROBLEM AND A STAFF RETRAINING WAS PERFORMED BY A POSEY EMPLOYEE AT THAT TIME. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION IF THE ISSUE SHOULD REOCCUR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED "THE STRAP OF THE 2532 SLIPPING THROUGH ITS BUCKLE AND NOT STAYING PUT". CUSTOMER REPORTED THE ISSUE OCCURRED APPROXIMATELY (B)(6) 2014 (SPECIFIC DATE UNKNOWN). CUSTOMER HAS NO OTHER PATIENT OR PRODUCT INFO. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230815 QUICK RELEASE LIMB HOLDERS FMQ J. T. POSEY CO. 2532 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK