BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL BODY SLING MESH LRG. 9153632094

    MDR report key: 6916985 · Received October 5, 2017

    Report

    Report Number
    1531186-2017-00013
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 11, 2017
    Manufacturer
    NEW PROKIN INTERNATIONAL LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN AUTHORIZATION WAS ISSUED, BUT THE SLING HAS NOT BEEN RECEIVED AT THIS TIME. A REPLACEMENT SLING WAS ORDERED AND SHIPPED TO THE FACILITY. WITHOUT AN EVALUATION OF THE SLING RELATED TO THIS EVENT, IT CAN NOT BE DETERMINED IF THERE WAS A MALFUNCTION. INVACARE IS FILING THIS RECORD IN AN ABUNDANCE OF CAUTION BASED ON UNCONFIRMED ALLEGATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE FACILITY REP STATES THE RESIDENT WAS UP IN THE LIFT AND THE SLING RIPPED. PER THE CALLER, THE SLING WAS JUST PROVIDED IN JULY BY THE LOCAL DME. THE CALLER STATES THE SLING RIPPED ON THE LEFT SIDE AND THE CONSUMER FELL TO THE FLOOR LANDING ON HER LEFT SIDE. THE CONSUMER WAS TRANSFERRED TO THE ER FOR EVALUATION AND TREATMENT. THE NURSE STATES THE ASSESSMENT PERFORMED BY STAFF ALLEGED THE CONSUMER HAS AN ABRASION AND BRUISE TO LEFT EYE AND ELBOW, BACK PAIN AND LEFT LEG FRACTURE. THE CONSUMER HAD X-RAYS AND REMAINED IN THE HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697754 FULL BODY SLING MESH LRG. 9153632094 NON-AC POWERED PATIENT LIFT FSA NEW PROKIN INTERNATIONAL LTD NA:R111

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization