BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP SLING

    MDR report key: 2469426 · Received February 14, 2012

    Report

    Report Number
    3004468271-2012-00005
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 18, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION #(B)(4)) ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS (B)(4) (REGISTRATION #(B)(4)). (B)(4). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NO A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS RAISING FROM A WHEELCHAIR WITH A MAXIMOVE WHEN ONE LOOP OF THE MAV SLING RUPTURED. RESIDENT DROPPED BACK 25CM TO THE WHEEL CHAIR NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOP SLING SLING FSA MEDIBO MEDICAL PRODUCTS NV MAV6375

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other