BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE-ALL SONTARA HLDR LIMB

    MDR report key: 5856195 · Received August 9, 2016

    Report

    Report Number
    5856195
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    April 12, 2016
    Report Date
    August 3, 2016
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2016 THE ICU STAFF NOTICED THAT THE HAND RESTRAINTS WERE BREAKING WHEN USED TO SECURE PATIENTS FROM PULLING IT OUT ENDOTRACHEAL TUBES. THE NURSING STAFF CALLED THE MANUFACTURER DJO AND REPORTED THE ISSUE WITH LOT NUMBERS AT THE TIME WITHOUT NOTIFYING ME SO THAT I COULD REPORT IT THROUGH MEDSUN. I'M TOLD THAT THE MANUFACTURER SENT THE ICU DEPARTMENT FREE PRODUCT REPLACEMENT AND SWAPPED OUT EVERYTHING IN STOCK FOR THE NEW ITEM THEY RECEIVED. ON (B)(6) 2016 THE NEW REPLACEMENT RESTRAINTS WERE DOING IT AGAIN. "TWO TIMES LATELY A VENTED PATIENT HAS BROKEN THE RESTRAINTS AND ONE OF THEM SELF-EXTUBATED BUT THE PATIENT WAS NOT HARMED. THEY SHRED AND BREAK VERY EASILY." I WAS GIVEN THE BROKEN ITEM. THEY APPEAR TO BE MADE OF COTTON FIBER OR PAPER. THE NUMBERS PROVIDED TO ME: "HLDR LIMB SECURE-ALL" LOT 1032455, MF #79-91470.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515495 SECURE-ALL SONTARA HLDR LIMB RESTRAINT, PROTECTIVE FMQ DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. 1032455

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR