BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELUXE SUPPORT SPACER SLING - MEDIUM

    MDR report key: 10332935 · Received July 28, 2020

    Report

    Report Number
    3007802293-2020-00013
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 9, 2020
    Report Date
    December 30, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE SLING WAS RETURNED AND INVESTIGATED. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. DESPITE STATIC LOAD TEST PERFORMED IN VARIOUS MISUSE SCENARIOS, THE FAILURE WAS NOT ABLE TO BE RECREATED. THIS TESTING, IN ADDITION TO THE 1.5 X SAFE WORKING LOAD STANDARD TESTING, DEMONSTRATES THAT THE FAILURE IS NOT CAUSED BY AN OVERLOAD. COMPLAINTS WILL BE MONITORED TO EVALUATE IF CORRECTIVE ACTION IS REQUIRED IN THE FUTURE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHEN LIFTING A USER FROM A SHOWER CHAIR TO HIS BED, A LEG STRAP CAME OFF THE SLING. THE USER FELL APPROXIMATELY 10 - 30 CM BACK INTO THE CHAIR AND WAS UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800510 DELUXE SUPPORT SPACER SLING - MEDIUM LIFTING SLING FSA HANDICARE USA INC. 8H4400

    Patients

    Seq Age Sex Outcome Treatment
    1