BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGRESS/ASSIST RAIL ASSEMBLY

    MDR report key: 1913769 · Received November 24, 2010

    Report

    Report Number
    3003984900-2010-00010
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A NUMBER OF FACTORS HAVE COME TOGETHER TO CAUSE THE EVENT; FIRST, IT IS UNK WHEN THE PLASTIC END CAP WENT MISSING, ONLY THAT THE STAFF AT FACILITY WERE AWARE THAT IT WAS MISSING PRIOR TO THE EVENT. NEXT, THE RESIDENT WAS TRANSFERRED BY ONLY ONE ASSISTANT AND THE RESIDENT REQUIRES A 2 PERSON ASSIST. FINALLY, THE CAP MISSING BEING FROM THE SIDE RAIL EXPOSING THE METAL. ALL THESE FACTORS ACTUALLY CONTRIBUTED TO THE INJURY. THE CAP HAS BEEN REPLACED AND ACCESSORY IS BACK IN USE. ALSO, ARJOHUNTLEIGH TECH MADE ROUNDS AT THE FACILITY AND INSPECTED THE OTHER EXISTING RENTAL BEDFRAMES AND SIDERAILS. THERE WERE NO OTHER SIDERAILS WITH MISSING ENDCAPS.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED BACK TO BED ON THE EVENING OF FRIDAY (B)(6) 2010, PRIOR TO 8 PM. TRANSFER WAS MADE BY ONLY 1 NURSES AIDE, FACILITY POLICY CALLED FOR ASSIST OF 2 AIDES. SIDE RAIL WAS IN THE UP POSITION AT THE HEAD OF THE BED ON THE RH SIDE. RESIDENT WAS HOLDING ON TO OVERBED TABLE DURING TRANSFER AND HIT HER LEG ON THE SIDE RAIL AS SHE WAS POSITIONED ON BED. THE PLASTIC END CAP WAS MISSING ON THE SIDE RAIL, EXPOSING THE METAL. IT APPEARS THAT THIS CAUSED THE LACERATION TO THE LEG. SUTURES AND STERI-STRIPS REQUIRED TO CLOSE THE WOUND. FACILITY MAINTENANCE WAS NOTIFIED AND COVERED METAL ON SIDE RAIL WITH BLACK ELECTRICAL TAPE. ARJOHUNTLEIGH WAS NOT NOTIFIED UNTIL (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGRESS/ASSIST RAIL ASSEMBLY BED ACCESSORY FNL ARJOHUNTLEIGH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R