BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE STRAP TAT CUFFS FOR WRIST

    MDR report key: 2920260 · Received December 17, 2012

    Report

    Report Number
    2020362-2012-00693
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 20, 2012
    Manufacturer
    J.T. POSEY COMPANY
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT WILL NOT SHUT CORRECTLY. THE CUSTOMER HAS TO APPLY EXCESSIVE FORCE TO BE ABLE TO CLOSE THE LOCKING MECHANISM. CUSTOMER REPORTED NO PHYSICAL DAMAGE TO THE UNIT AND THIS WAS DISCOVERED DURING ROUTINE MAINTENANCE OF THE PRODUCT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE STRAP TAT CUFFS FOR WRIST FMQ J.T. POSEY COMPANY 2798 061511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA