BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUADTRO SELECT CUSHION

    MDR report key: 418946 · Received September 8, 2002

    Report

    Report Number
    1419507-2002-00001
    Event Type
    Other
    Date Received
    September 8, 2002
    Date of Event
    July 1, 2002
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONTRARY TO INSTRUCTIONS ON THE PRODUCT AND IN THE OPERATIONS MANUAL ACCOMPANYING THE PRODUCT TO CHECK THE AIR LEVEL DAILY, THE CUSTOMER CONTINUED TO SIT ON A FLAT CUSHION FOR 8-10 DAYS AND DEVELOPED A RED SPOT ON THEIR BUTTOCKS. THE CUSTOMER'S PHYSICIAN INSTRUCTED PATIENT TO STAY OFF OF THEIR BUTTOCKS, BUT THE CUSTOMER CONTINUED TO SIT ON THE CUSHION, RESULTING IN A PRESSURE SORE THAT NECESSITATED A DEBRIDEMENT PROCEDURE IN THE HOSPITAL. THE CUSTOMER'S SORE IS REPORTED TO BE HEALED. ADDITIONALLY, THE OPERATIONS MANUAL INSTRUCTS THE USER IN VIGILENCE AGAINST DEFLATION AND "BOTTOMING OUT", AND STEPS TO TAKE IF EITHER OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADTRO SELECT CUSHION FLOTATION THERAPY CUSHION CLASS I-510 (K) EXEMPT KIC ROHO, INC. UNK QUADTRO SELECT CUSHION *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization