BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAY CUSHION

    MDR report key: 62398 · Received January 16, 1997

    Report

    Report Number
    1720745-1997-00001
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    December 1, 1996
    Report Date
    December 17, 1996
    Manufacturer
    JAY MEDICAL LTD
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER IS CONFINED TO A WHEELCHAIR. INITIAL REPORT FROM RETAIL DISTRIBUTOR WAS THAT USER HAD STAGE 3 PRESSURE SORE. USER REPORTED SKIN BREAKDOWN & TREATMENT WITH DRESSINGS IN HOSPITAL. THE USER WAS USING AN OBSOLETE CONFIGURATION OF A MODEL 100 CO'S (WHEELCHAIR CUSHION). THIS WHEELCHAIR CUSHION MAY HAVE BEEN ONE OF THE MANY FACTORS THAT MAY HAVE AFFECTED SKIN INTEGRITY IN THIS CASE. OTHER FACTORS INCLUDE: PROPER DIET, HYGIENE, REGULARPRESSURE RELIEFS, PHYSICAL CHANGES, POSITIONING, AND TIGHT CLOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAY CUSHION WHEELCHAIR CUSHION KIC JAY MEDICAL LTD 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R WHEELCHAIR