BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCARE EXTRA LARGE CARE SLING W/HEAD SUPPORT - KNIT

    MDR report key: 10251386 · Received July 9, 2020

    Report

    Report Number
    3007802293-2020-00011
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 19, 2020
    Report Date
    October 16, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGES OF THE SLING WERE REVIEWED AS THE SLING WAS NOT RETURNED. FOR ALL FOUR STRAPS TO FAIL SIMULTANEOUSLY THERE WOULD HAVE TO BE SOME SORT OF EXTERNAL PRESSURE OR CUTTING DUE TO THE HOOKS OF THE CARRY BAR BEING ROUGH OR PITTED. HOWEVER, PICTURES OF THE FLOOR LIFT WITH CARRY BAR WERE NOT PROVIDED TO CONFIRM THIS THEORY. THIS SLING FAMILY HAS BEEN LOAD TESTED AT 1500 LBS 1.5X THE SAFE WORKING LOAD OF 1000LBS. THE SLING WAS REMOVED FROM SERVICE.

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING FURTHER DETAILS AND THE PRODUCT FROM THE FACILITY. A FOLLOW-UP REPORT WILL BE FILED WITH THE RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A USER WAS BEING TRANSFERRED BY TWO NURSES AND TWO CNAS. FOUR STRAPS OF THE SLING BROKE. THE USER FELL TO THE FLOOR AND IS IN PAIN. NO INJURIES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713115 MEDCARE EXTRA LARGE CARE SLING W/HEAD SUPPORT - KNIT LIFTING SLING FSA HANDICARE USA INC. 400034

    Patients

    Seq Age Sex Outcome Treatment
    1