BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM MULTI-PURPOSE SLING, KNIT STYLE

    MDR report key: 3964229 · Received July 14, 2014

    Report

    Report Number
    3007802293-2014-00020
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 11, 2014
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SLING WILL NOT BE RETURNED TO THE MANUFACTURER BECAUSE THE INCIDENT WAS DUE TO USER ERROR. A STAFF SENIOR SAFE PATIENT HANDLING CONSULTANT IS IN CONTACT WITH THE FACILITY TO ADMINISTER FURTHER TRAINING.

    Description of Event or Problem · 1

    TWO STAFF WERE USING A MEDIUM MULTI-PURPOSE SLING WITH A MEDCARE FLOOR LIFT TO TRANSFER A PATIENT. THE PATIENT FELL FEET FIRST OUT OF THE SLING. THE PATIENT FELL OUT FORWARD BECAUSE SHE WAS NOT POSITIONED CORRECTLY. THE PATIENT WENT IN FOR AN X-RAY AND IT WAS FOUND THAT SHE FRACTURED HER RIGHT TIBIA/FIBULA, LEFT FEMUR, AND PUBIC RAMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410054 MEDIUM MULTI-PURPOSE SLING, KNIT STYLE MULTI-PURPOSE KNIT SLING FSA 400025

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization