BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY E.D. SECURITY CUFFS - KEYLOCK

    MDR report key: 3888348 · Received April 10, 2014

    Report

    Report Number
    2020362-2014-00143
    Event Type
    Malfunction
    Date Received
    April 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. EVALUATION REVEALED THAT THE LOCK #1, CLOSES WITH OR WITHOUT THE STRAP FED THROUGH AND CLICKS SHUT. THE KEY IS STILL ABLE TO UNLOCK THE LOCK. LOCK #2, CLOSES WITH AND WITHOUT THE STRAP FED THROUGH AND LOCKS. THE KEY IS STILL ABLE TO UNLOCK THE LOCK, BUT MUST MANUALLY PULL THE LOCK APART TO OPEN IT. HOWEVER, BOTH OF THE LOCKS HAVE THE KEY POST MISSING. THE RIVETS THAT HOLD THE LOCKS TOGETHER ARE ALSO MISSING. NOTE: INSTRUCTIONS FOR USE STATE: BEFORE EACH USE, CHECK CUFFS AND STRAPS FOR CRACKS, TEARS, AND/OR EXCESSIVE WEAR OR STRETCH; CRACKED OR BROKEN BUCKLES OR LOCKS; AND/OR THAT HOOK AND LOOP ADHERES SECURELY, AS THESE MAY ALLOW PT TO REMOVE CUFF. DISCARD IF DEVICE IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE THREADING THE TONGUE THROUGH THE METAL BUCKLE THE INTERNAL PARTS OF THE MECHANISM CAME APART. THE ISSUE WAS DISCOVERED DURING SETUP, BUT THE DATE IS UNK. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216399 POSEY E.D. SECURITY CUFFS - KEYLOCK FMQ J. T. POSEY CO. 2835 2007-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA