BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYESTER W/COMMODE OPENING 9153618908

    MDR report key: 7715129 · Received July 24, 2018

    Report

    Report Number
    1531186-2018-00005
    Event Type
    Injury
    Date Received
    July 24, 2018
    Report Date
    June 28, 2018
    Manufacturer
    NEW PROKIN INTERNATIONAL LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 9043 SLING HAS NOT BEEN RETURNED TO INVACARE. THERE IS NO ALLEGATION OF A DEFECT OR MALFUNCTION, THE 9043 SLING IS NOT THE RIGHT FIT FOR THE PT.¿S NEEDS. SHOULD ANY FUTURE INFORMATION SUGGEST A DEFECT OR MALFUNCTION OF THE PRODUCT INVACARE WILL UPDATE THE RECORD ACCORDINGLY.

    Description of Event or Problem · 1

    THE CONSUMER WAS IN A 9043 SLING WHEN SHE SLID OUT OF THE SLING FEET FIRST BREAKING HER LEFT TIBIA. THE END USER IS STATING THAT SHE NEEDS A DIVIDED LEG SLING TO BETTER SUIT HER NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555827 POLYESTER W/COMMODE OPENING 9153618908 LIFT, PATIENT, NON-AC-POWERED FSA NEW PROKIN INTERNATIONAL LTD NA:9043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention