BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWICE-AS-TOUGH CUFFS, WRIST PAIR, KEY LOCK CUFF AND STRAP

    MDR report key: 3071178 · Received April 8, 2013

    Report

    Report Number
    2020362-2013-00159
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 12, 2013
    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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. NOTE: INSTRUCTIONS FOR USE STATES: LAUNDERING INSTRUCTIONS (IF APPLICABLE): FASTEN ALL BUCKLES AND LOCKS TO REDUCE RISK OF DAMAGE DURING WASH AND DRY CYCLES. DO NOT PUT BUCKLES OR LOCKS THROUGH EXTRACTORS. FOR MAXIMUM LIFE, LAUNDER IN A LAUNDRY BAG. BEFORE LAUNDERING, ZIP UP AND TURN THE PRODUCT INSIDE OUT TO PROTECT ZIPPER. HOOK AND LOOP FASTENERS MAY COLLECT LINT AFTER REPEATED USE OR LAUNDERING, REDUCING GRIP STRENGTH. FASTEN THE "HOOK" TO THE "LOOP" BEFORE LAUNDERING TO HELP PREVENT LINT BUILDUP. AS NEEDED, USE A STIFF-BRISTLE BRUSH TO REMOVE LINT FROM THE "HOOK" SIDE. FOR NON-CONTAMINATED MATERIAL, USE LOWER TEMPERATURE WASH AND DRY CYCLES TO EXTEND PRODUCT LIFE. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT AFTER A HOSPITAL TESTED THE TWICE AS TOUGH CUFFS BY WASHING IT TEN TIMES IN 60 CELSIUS (140 F) TEMPERATURE WATER, THE TWO LOCKS BECOME IMPOSSIBLE TO CLOSE DURING TEST. THE DISTRIBUTOR REPORTED THE PRODUCT IS WASHED IN NETS. THE DISTRIBUTOR DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT/PERSONNEL INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144560 TWICE-AS-TOUGH CUFFS, WRIST PAIR, KEY LOCK CUFF AND STRAP FMQ J. T. POSEY CO. 2798 102711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA