BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2081425 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00177
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 28, 2011
    Manufacturer
    INVAMEX
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTEDLY WAS BEING TRANSFERRED WHEN THE PIN ALLEGEDLY SHEARED OFF IN THE ARM OF THE BOOM, CAUSING THE PATIENT TO FALL AND REQUIRE STITCHES FOR A CUT ON THEIR LEG. DEVICE HAS BEEN IN SERVICE FOR 2 YEARS WITH NO PRIOR REPORTED INCIDENTS. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    THE STAFF WAS PIVOTING THE CONSUMER WHILE IN THE SLING, WHEN THE PIN ALLEGEDLY SHEARED OFF IN THE ARM OF THE BOOM. THIS ALLEGEDLY CAUSED THE CONSUMER TO FALL AND CUT HER LEG, RESULTING IN STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention