BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL FOAM CUSHION

    MDR report key: 2992891 · Received March 1, 2013

    Report

    Report Number
    1417592-2013-00019
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER IS A BILATERAL ABOVE THE KNEE AMPUTEE WHO SITS AND SLEEPS IN HIS WHEELCHAIR. HE SAT ON A BASIC WHEELCHAIR CUSHION AND DEVELOPED BILATERAL STAGE III PRESSURE ULCERS ON HIS THIGHS. HIS HOME CARE NURSES HAD RECOMMENDED AN ADVANCED GEL CUSHION BUT HIS INSURANCE COMPANY WOULD NOT COVER IT. THE HOME CARE NURSES ARE TREATING THE PRESSURE ULCERS WITH WOUND DRESSINGS. THE CUSHION IS INTENDED TO ADD COMFORT AND BASIC PRESSURE REDISTRIBUTION. IT IS NOT INTENDED TO PREVENT A PRESSURE ULCER. A SKIN MANAGEMENT PROGRAM INCLUDES REGULARLY SCHEDULED SKIN ASSESSMENTS AND FREQUENT POSITION CHANGES TO REDUCE PROLONGED PRESSURE TO ONE AREA. THE END USER DESCRIBED PROLONGED AND UNINTERRUPTED PERIODS OF TIME IN HIS WHEELCHAIR. THE CUSHION DID NOT CAUSE THE PRESSURE ULCERS BUT IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE END USER DEVELOPED PRESSURE ULCERS WHILE SITTING ON THE CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89314 GEL FOAM CUSHION KNN MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention