BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER HML-400 LIFT WITH HOYER SLING

    MDR report key: 2531818 · Received March 31, 2012

    Report

    Report Number
    2182305-2012-00011
    Event Type
    Malfunction
    Date Received
    March 31, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 28, 2012
    Manufacturer
    STARITE INTERNATIONAL, LTD.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SLING MANUFACTURER IS STARITE INTERNATIONAL (B)(4). THE LIFT MANUFACTURER IS APEX HEALTHCARE MFG. INC., (B)(4). JOERNS IS SENDING REPORT TO LIFT MANUFACTURER. JOERNS IS SENDING REPORT TO SLING MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR, BY USER, PER USER, A PHYSICAL THERAPIST WAS LIFTING HIS WIFE OFF THE BED WHEN THE SLING STRAP STITCHING FAILED. PER USER, PATIENT FELL BACK ONTO BED, NO INJURIES WERE REPORTED. FOLLOW UP CONFIRMED THAT THE PATIENT SUSTAINED NO INJURY. PER USER, THE PHYSICAL THERAPIST LIFTED THE PATIENT WHILE IN THE PRONE POSITION. THEY LIFTED THE PATIENT APPROX 1 FOOT OFF THE BED. THE PATIENT DID NOT RECLINE INTO THE SITTING POSITION WHEN LIFTED AS HE EXPECTED. THE LIFT CONTAINING THE PATIENT CLEARED THE BED WHEN ONE OF THE SHOULDER STRAPS RIPPED CAUSING THE SHOULDER TO DROP. THE PATIENT ROLLED ONTO THE FLOOR WITH ONE ARM AND SHOULDER ON THE LEG OF THE LIFT. THE LIFT WAS REMOVED FROM UNDER THE PATIENT AND THE PATIENT'S LEGS WERE LOWERED TO THE FLOOR. THIS IS A DIFFERENT ACCOUNT THAN FIRST REPORTED. (B)(4) WAS ENTERED INTO SYSTEM TO RETRIEVE THE SLING BACK FOR EVALUATION. PRELIMINARY EVALUATION INDICATES THAT THE STITCHING MAY HAVE COME LOOSE. THE SLING ARRIVED AT THE MFR THE DAY BEFORE THIS REPORT AND IS CURRENTLY BEING EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER HML-400 LIFT WITH HOYER SLING PATIENT LIFT WITH SLING FNG STARITE INTERNATIONAL, LTD. HML-400/70010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR