BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM CARE SLING W/HEAD SUPPORT - KNIT

    MDR report key: 10390183 · Received August 11, 2020

    Report

    Report Number
    3007802293-2020-00015
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 14, 2020
    Report Date
    October 16, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGES OF THE SLING AND ASSOCIATED FLOOR LIFT WERE REVIEWED AS THE SLING AND LIFT WERE NOT RETURNED. THE HOOKS OF THE FLOOR LIFT'S CARRY BAR WERE RUSTED AND ABRASIVE, APPEARING AS IF IT WAS STORED OUTSIDE OR IN A WET ENVIRONMENT. THE STRAPS WERE LIKELY CUT BY THE ROUGH SURFACE OF THE HOOKS. THIS SLING FAMILY HAS BEEN LOAD TESTED TO 1000 LBS., AND THE STRAPS HAVE A BREAKING STRENGTH OF 700 LBS. SO THE 230 LB. USER WAS WELL WITHIN THE LIMITS OF THIS PRODUCT. THE SLING WAS REMOVED FROM SERVICE.

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED MORE DETAILS ABOUT THIS INCIDENT AND FOR THE SLING TO BE RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH MORE INFORMATION.

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED WITH A MEDICARE TOTAL LIFT & WEIGH AND MEDIUM CARE SLING W/HEAD SUPPORT - KNIT. WHEN THE RESIDENT WAS A FEW INCHES ABOVE THE MATTRESS, THREE STRAPS OF THE SLING BROKE AND THE RESIDENT FELL ONTO THE MATTRESS. THE RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853873 MEDIUM CARE SLING W/HEAD SUPPORT - KNIT LIFTING SLING FSA HANDICARE USA INC. 400030

    Patients

    Seq Age Sex Outcome Treatment
    1