BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MESH/POLY SLING WITH HEAD SUPPORT

    MDR report key: 11655132 · Received April 13, 2021

    Report

    Report Number
    3007802293-2021-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 3, 2021
    Manufacturer
    HANDICARE USA, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS WERE PROVIDED OF THE SLING INVOLVED IN THE INCIDENT; THE SLING WAS NOT RETURNED FOR INVESTIGATION. THE SHOULDER LOOPS HAVE ORANGE STITCHING USED AS IDENTIFICATION MARKERS WHICH ARE NOT LOAD BEARING. THE BROKEN LOOP, WHICH HAD ORANGE STITCHING, WAS CONFIRMED. OTHER STRAPS WERE INSPECTED AND WERE INTACT. THE ROOT CAUSE OF THE TOP LEFT SHOULDER STRAP LOOP BREAKING IS DUE TO EXCESS WEAR ON THE SHOULDER STRAPS. THE ORANGE STITCHING REDUCES THE FLEXIBILITY OF THE STRAP WHEN IT IS UNDER LOAD. ORANGE STITCHING HAS BEEN REMOVED FROM SLINGS MOVING FORWARD TO IMPROVE FLEXIBILITY OF THE STRAP. THE FAILURE IS NOT A RESULT OF A SUDDEN PRODUCT MALFUNCTION, BUT RATHER CAUSED OVER A LONG-TERM PERIOD OF USE. THE WEAR SHOULD BE NOTED BY THE CAREGIVER PRIOR TO LIFTING THE USER. THE INSTRUCTIONS PROVIDED WITH EACH SLING DIRECT THE USER TO VISUALLY INSPECT THE SLING AND STRAPS PRIOR TO AND DURING A PATIENT TRANSFER. THESE INSTRUCTIONS ARE DEEMED SUFFICIENT.

    Description of Event or Problem · 1

    RESIDENT WAS BEING LIFTED IN THE TUB ROOM FROM HER WHEELCHAIR WITH ALL STRAPS ATTACHED TO THE CARRY BAR. AS THE LIFT WAS ENGAGED AND THE PATIENT LIFTED INCHES ABOVE HER CHAIR, THE STRAP FOR THE RESIDENT'S RIGHT LEG FAILED AND HER LEG FELL ONTO THE CHAIR. RESIDENT WAS IMMEDIATELY LOWERED BACK INTO CHAIR. THERE WERE NO INJURIES TO THE RESIDENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556433 UNIVERSAL MESH/POLY SLING WITH HEAD SUPPORT CEILING LIFT SLING FSA HANDICARE USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR