BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY BIOTHANE RESTRAINT

    MDR report key: 2446408 · Received January 18, 2012

    Report

    Report Number
    2020362-2012-00009
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Report Date
    December 20, 2011
    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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: INSPECTION OF THE RETURNED PRODUCT SHOWS THE CUFF WAS RECEIVED WITH THE LOOK NOT ATTACHED TO THE BIOTHANE STRAP. THE RIVETS HOLDING THE LOCK STRAP CAME LOOSE FROM THE CUFF STRAP, BUT THE LOCK ITSELF WAS NOT BROKEN. THE LOCK FUNCTIONED PROPERLY WHEN THE KEY WAS USED TO UNLOCK IT. NOTE: INSTRUCTIONS FOR USE WARNING: 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 LOP ADHERES SECURELY, AS THESE MAY ALLOW PATIENT TO REMOVE CUFF. DISCARD IF DEVICE IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LOCK IS BROKEN. THE RIVETS THAT ARE ANCHORING THE LOCK TO THE CUFF HAS LET GO DURING USE. CUSTOMER IS NOT SURE HOW THIS HAPPENED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BIOTHANE RESTRAINT FMQ J. T. POSEY CO. 2900 091510

    Patients

    Seq Age Sex Outcome Treatment
    1 NI