BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE SLING

    MDR report key: 18827442 · Received March 4, 2024

    Report

    Report Number
    1525712-2024-00003
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    December 27, 2023
    Report Date
    March 1, 2024
    Manufacturer
    UNKNOWN
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 5, 2024, INVACARE WAS MADE AWARE OF AN EVENT THAT OCCURRED IN FRANCE INVOLVING AN INVACARE SLING. IT IS UNCLEAR WHICH MODEL SLING WAS INVOLVED IN THIS INCIDENT AND THUS THE MANUFACTURER IS UNKNOWN, THEREFORE, FOR PURPOSES OF FILING THE INVACARE CORPORATION OH/USA REGISTRATION IS BEING UTILIZED. DUE TO THE SAME SLINGS MAY HAVE BEEN SOLD IN THE US THIS MEDWATCH IS BEING FILED IN AN ABUNDANCE OF CAUTION. THE CAUSE OF THE PATIENT TO FALL HAS NOT BEEN DETERMINED. A MALFUNCTION OF THE SLING HAS NOT BEEN ALLEGED. THIS EVENT MAY BE THE RESULT OF USE ERROR. INVACARE FRANCE HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS INCIDENT WHICH INCLUDES: CLARIFICATION OF THE SLING MODEL NUMBER, THE LIFT MODEL NUMBER AND FOR A RETURN OF THE PRODUCT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT ON (B)(6) 2023, A RESIDENT WAS BEING TRANSFERRED USING A SLING, LIFT AND TRANSFER RAIL. DURING THE TRANSFER, THE RESIDENT¿S RIGHT LEG SLIPPED BENEATH HER CAUSING HER TO FALL ON HER RIGHT SIDE. THE RESIDENT SUSTAINED TWO BUMPS, ONE ON THE BACK OF HER HEAD RIGHT SIDE AND ONE ON HER FOREHEAD RIGHT SIDE. THE RESIDENT¿S CONDITION WAS MONITORED, BUT SUBSEQUENTLY AFTER A CHANGE OF STATUS AND SPASMS OF THE RIGHT HEMIFACE, THE RESIDENT WAS SENT TO THE HOSPITAL FOR A CT SCAN. THE CT SCAN SHOWED A SUBDURAL HEMATOMA. THE PATIENT WAS HOSPITALIZED FOR MONITORING AND TREATMENT OF THE SPASMS. THE PATIENT LATER DIED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710604 INVACARE SLING LIFT, PATIENT, NON-AC-POWERED FSA UNKNOWN NOT AVAILABLE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death