BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-PURPOSE SLING

    MDR report key: 4003080 · Received June 25, 2014

    Report

    Report Number
    3007802293-2014-00019
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 25, 2014
    Manufacturer
    PRISM MEDICAL SERVICES USA
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SLING WAS MADE IN 2012 BY (B)(4)., A SLING SUPPLIER TO MEDCARE PRODUCTS. (B)(4). THE SLING WAS SOLD TO THE CUSTOMER IN (B)(6) 2013. (B)(4) PURCHASED MEDCARE IN (B)(4) 2014.

    Description of Event or Problem · 1

    A NURSE WAS TRANSFERRING A FEMALE PATIENT OUT OF BED USING A 475 LBS. MEDCARE LIFT WITH A MEDCARE XL MULTI-PURPOSE SLING. THE STRAP OF THE SLING RIPPED OFF AND THE PATIENT FELL APPROXIMATELY 4 FEET TO THE FLOOR AND HIT HER HEAD. THE PATIENT WAS COMPLAINING OF A SORE HEAD AND BACK. SHE WENT IN FOR AN MRI BUT NO INJURIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369672 MULTI-PURPOSE SLING MULTI-PURPOSE SLING FSA PRISM MEDICAL SERVICES USA 103404

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR