BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAKED CUSHION SEAT

    MDR report key: 8508542 · Received April 12, 2019

    Report

    Report Number
    1525712-2019-00009
    Event Type
    Injury
    Date Received
    April 12, 2019
    Report Date
    March 28, 2019
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE DEALER REPORTED THAT THE END USER DEVELOPED A STAGE 3 PRESSURE WOUND IN MID-FEBRUARY, AFTER THE CM02S SEATING WAS RECEIVED AND INSTALLED ON THEIR WHEELCHAIR. THE CUSHION WAS DELIVERED ON JANUARY 28, 2019. THE END USER WAS RECEIVING WOUND CARE BY HAVING THE SORE PACKED AND IS NOW HAVING IT TREATED TOPICALLY AT HOME. THE END USER PARENTS HAVE REMOVED THE CUSHION FROM THE CONTOUR U AND STARTED USING THE OLD CUSHION. THE DEALER REPORTED, THAT HE HAS CUT OUT ABOUT ONE AND A HALF INCH INTO THE PELVIC WELL AREA, AND FILLED IT WITH GEL PACKS TO GIVE THE END USER SOME COMFORT AND RELIEF. THE END USER HAS A LOT OF TONE AND SPASM ISSUES.

    Additional Manufacturer Narrative · 1

    IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED TO THE FDA, DUE TO THE ALLEGED INJURY AND MEDICAL TREATMENT REQUIRED. THERE WAS NO ALLEGED MALFUNCTION/DEFICIENCY WITH THE DEVICE. THE CONTOURU CUSHIONS ARE CUSTOMIZED TO THE INDIVIDUAL USER, AND THIS CUSHION WAS MADE ACCORDING TO THE SPECIFICATIONS PROVIDED BY THE DEALER. THE DEALER STATED HE HAS MODIFIED THE CUSHION BY CUTTING OUT ABOUT ONE AND HALF INCH INTO THE PELVIC WELL AREA AND FILLED WITH GEL PACKS TO GIVE THE END USER SOME COMFORT AND RELIEF. IF MORE INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REVISITED.

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE END USER DEVELOPED A STAGE 3 PRESSURE WOUND IN MID-(B)(6), AFTER THE CM02S SEATING WAS RECEIVED AND INSTALLED ON THEIR WHEELCHAIR. THE CUSHION WAS DELIVERED ON (B)(6) 2019. THE END USER WAS RECEIVING WOUND CARE BY HAVING THE SORE PACKED AND IS NOW HAVING IT TREATED TOPICALLY AT HOME. THE END USER PARENTS HAVE REMOVED THE CUSHION FROM THE CONTOUR U AND STARTED USING THE OLD CUSHION. THE DEALER REPORTED, THAT HE HAS CUT OUT ABOUT ONE AND A HALF INCH INTO THE PELVIC WELL AREA, AND FILLED IT WITH GEL PACKS TO GIVE THE END USER SOME COMFORT AND RELIEF. THE END USER HAS A LOT OF TONE AND SPASM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301144 NAKED CUSHION SEAT CUSHION, FLOTATION KIC INVACARE TAYLOR STREET NA:CM02S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other