BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM CARE SLING - KNIT STYLE

    MDR report key: 10658669 · Received October 9, 2020

    Report

    Report Number
    3007802293-2020-00019
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 9, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), HANDICARE'S RESPONSIBLE TERRITORY MANAGER FOR THE FACILITY, VISITED THE FACILITY TO INSPECT THE EQUIPMENT INVOLVED. HE SPOKE TO THE CAREGIVERS, AND CLARIFIED HOW THE INCIDENT OCCURED: THE SLING WAS THE CORRECT SIZE FOR THE USER. THE SLING WAS HOOKED TO THE CARRY BAR SECURELY; IT DID NOT COME OFF THE CARRY BAR. THE LEG STRAPS WERE CROSSED HOOKING UP SHORTEST ON SHOULDERS, AND MEDIUM ON LEGS WHICH CREATES A MORE RECLINED POSITION. THE USER HAS LEFT SIDE WEAKNESS, AND SLID OUT ON THE LEFT SIDE OF THE SLING. THE ROOT CAUSE OF THIS INCIDENT WAS USER ERROR; THE EQUIPMENT DID NOT MALFUNCTION. THE CAREGIVERS MUST TAKE CARE TO ENSURE THE SLING IS PROPERLY POSITIONED AT ALL TIMES DURING TRANSFER. DURING THIS VISIT, (B)(4) INSPECTED THE SLING INVOLVED. IT HAD NO STRUCTURAL ISSUES. AS IT WAS PAST THE EXPECTED LIFE OF THE SLING, HE REMOVED IT FROM SERVICE. HE ALSO CONDUCTED TRAINING ON THE USAGE OF THE SLINGS WITH FLOOR LIFTS, AND CEILING LIFTS ON OCTOBER 1, 2020.

    Description of Event or Problem · 1

    TWO CAREGIVERS WERE TRANSFERRING THE USER USING A CARE LIFT-N-WEIGH 600 (MODEL NUMBER 400013) FROM A BED TO A WHEELCHAIR. AS THE PATIENT WAS MOVED TOWARDS THE WHEELCHAIR, SHE SLID OUT THE SIDE OF THE SLING, AND LANDED ON THE FLOOR. THE PATIENT HAD A LACERATION ON HER FOREHEAD, AND A FEW SCRATCHES ON THE TOP OF HER HEAD. SHE WAS EVALUATED AT THE HOSPITAL, AND RELEASED AFTER APPROXIMATELY 2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120514 MEDIUM CARE SLING - KNIT STYLE LIFTING SLING FSA HANDICARE USA INC. 400020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization