BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX

    MDR report key: 2759874 · Received September 15, 2012

    Report

    Report Number
    MW5027033
    Event Type
    Malfunction
    Date Received
    September 15, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 15, 2012
    Manufacturer
    APEX DYNAMICS HEALTHCARE PRODUCTS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A SL-TP331 APEX TOILETING SLING FROM SPINLIFE.COM ((B)(4)) ON (B)(6) 2012. THIS IS USED ON A HOYER LIFT TO PICK UP MY WIFE WHO IS A QUADRIPLEGIC. BY (B)(6) 2012, I SAW ONE OF THE LOOPS THAT HOOKS ONTO THE LIFT HAD BADLY FRAYED CAUSED BY CONTACTING VELCRO ON ANOTHER PART OF THE SLING. THIS IS A DEFINITE SAFETY ISSUE AND COULD CAUSE MY WIFE TO FALL. I CALLED SPINLIFE AND TOLD THEM ABOUT THIS AND THEIR SUPPLIER SAID I MUST HAVE CUT THE STRAP AND WOULD NOT REPLACE IT. I HAVE PICTURES OF THE FRAYED STRAP. WELL, I ORDERED ANOTHER ONE ANYWAY ON (B)(6) 2012. NOW ON (B)(6) 2012 WE FIND THE VERTICAL SIDE STITCHING IS COMING APART ON ONE SIDE. THIS COULD CAUSE A COMPLETE FAILURE AND DROP MY WIFE. I ALSO HAVE PICTURES OF THE DEFECT ON THE SIDE STITCHING. THESE ARE SERIOUS ISSUES AS THESE ARE USED NOT ONLY BY ME BUT NURSING HOMES AND HOSPITALS. I WILL CONTACT SPINLIFE ON MONDAY (B)(6) 2012 AND NOTIFY THEM OF ANOTHER FAILURE AND TRY AND GET MY MONEY BACK. OH I HAVE BEEN USING A SLING MADE BY ALLIANCE #19512 WHICH LOOKS EXACTLY LIKE THE APEX MODEL FOR OVER A YEAR (I HAVE 2 OF THESE) WITHOUT ANY SIGNS OF OTHER THAN NORMAL WEAR. I ORDERED THE APEX SLING BECAUSE THEY HAVE A SMALL MODEL WHILE THE ALLIANCE DOESN'T MAKE THIS SIZE. NOTE MY WIFE WEIGHTS (B)(6). SLING RATED 400 LBS. PLEASE HELP ME IF YOU CAN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX TOILETING SLING IKX APEX DYNAMICS HEALTHCARE PRODUCTS SL-TP331

    Patients

    Seq Age Sex Outcome Treatment
    1