BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAN CUFFS, KIT (WRIST AND ANKLE SET)

    MDR report key: 1550113 · Received November 11, 2009

    Report

    Report Number
    2020362-2009-00675
    Event Type
    Malfunction
    Date Received
    November 11, 2009
    Date of Event
    October 9, 2009
    Report Date
    October 14, 2009
    Manufacturer
    POSEY, S. DE R. L. DE C.V.
    Product Code
    FMQ
    PMA / PMN Number
    K963413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT # 04/2009. ADD'L MANUFACTURE DATE: 04/2009. (B) (4). PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A PATIENT ON A 18" MATTRESS ON A METAL FRAME (NOT A STANDARD HOSPITAL BED), WITH ALL FOUR LIMBS IN THE CLEAN CUFFS. ALL FOUR CUFFS WERE ATTACHED TO A NYLON STRAP THAT WERE LOOPED AROUND A METAL RINGS ANCHORED TO METAL FLOOR BRACE. THE PATIENT WAS ACTING BELLIGERENT AND TELLING THE STAFF THAT HE WAS GOING TO GET OUT OF THE RESTRAINTS. THE PATIENT WAS TWISTING HIS WRISTS AND ANKLES. THE PATIENT MANAGED TO BREAK THE TIP OF THE POST IN THREE OF THE FOUR CUFF LOCKS. AN ANKLE CUFF WAS STILL LOCKED ON THE PATIENT. THERE WAS NO PATIENT OR PERSONNEL INJURY. POSEY'S APPLICATIONS INSTRUCTIONS STATE TO USE THE STRAP AND CUFF ON A HOSPITAL BED WITH A SIDE RAIL AND TO WRAP THE NYLON STRAP AROUND THE MOVEABLE PART OF THE RAIL TO TAKE UP THE SLACK SO THAT THE PATIENT CANNOT DAMAGE THE LOCK BY PULLING ON THE EXCESS STRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN CUFFS, KIT (WRIST AND ANKLE SET) FMQ POSEY, S. DE R. L. DE C.V. 2216 06/2009

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR