BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI SLING

    MDR report key: 2924613 · Received January 11, 2013

    Report

    Report Number
    2924613
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 11, 2013
    Manufacturer
    TOLLOS, INC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHEN GETTING READY TO USE THE CEILING LIFT THIS MORNING, THE PHYSICAL THERAPIST DISCOVERED A TEAR IN THE COMBI SLING AT ONE OF THE LOOPS USED TO PULL A PATIENT BACKWARD INTO THE CHAIR. (THIS WAS NOT A LOOP THAT ATTACHES TO THE CEILING LIFT). THE SLING HAD BEEN ISSUED TO THE PATIENT ON ADMISSION YESTERDAY. IT IS UNKNOWN WHEN THE TEAR OCCURRED. THE SLING WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18722 COMBI SLING LIFT, PATIENT FSA TOLLOS, INC * 1631210BE

    Patients

    Seq Age Sex Outcome Treatment
    1 *