BEUDAMED
    FDA Adverse Event Other Summary report: N

    BYE-BYE-DECUBITI MATTRESS OVERLAY

    MDR report key: 242193 · Received September 27, 1999

    Report

    Report Number
    MW1017236
    Event Type
    Other
    Date Received
    September 27, 1999
    Date of Event
    December 8, 1998
    Manufacturer
    KEN MCRIGHT SUPPLIES INC.
    Product Code
    IKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN INFLATED MATTRESS OVERLAY, USED TO CURE A DECUBITUS ON A PARAPLEGIC WENT FLAT SEVERAL TIMES. ITS USE WAS DISCONTINUED BECAUSE IT WAS DANGEROUS. DEFECTIVELY DESIGNED. THE SELLER WOULDN'T GIVE A $731.50 REFUND EVEN THOUGH HE TOLD THE BUYER "IT WOULD LAST 10 YEARS WITHOUT AN AIR LEAK," AND HIS AD STATES, "SATISFACTION GUARANTEED," IN A LETTER TO THE BUYER (BEFORE HE ASKED FOR A REFUND). THE SELLER STATES, "DESIGN AND VULCANIZATION CHANGES MAY ELIMINATE THE PROBLEM". PURCHASED ON 2/10/98; PUT TO USE 9/10/98. DISCONTINUED USE 6/19/99. THE TOP RUBBER LAYER SEPARATED FROM THE BOTTOM LAYER, PRODUCING UNREPAIRABLE LEAKS, MAKING UNIT DANGEROUS AND USELESS FOR CURING DECUBITUS. BECAUSE OF ITS SIZE AND SOFTNESS OF RUBBER IT "BOTTOMS-OUT" TOO EASILY. A MAJOR PROBLEM TOO. MFR ADMITS DEFECTS AFTER TRYING TO BLAME THE USER. USED THIS DEVICE FOR DECUBITUS AND IT SHOWED NO SIGN OF HEALING OR IMPROVING. IT MAY HAVE AGGRAVATED THE CONDITION. MFR SENT A REPLACEMENT WITH SLIGHT COSMETIC BLEMISH AS PROMISED. PER MFR: "IF USED ACCORDING TO THE FOLLOWING INSTRUCTIONS, IT SHOULD HOLD UP BETTER (MUCH BETTER THAN THE PREVIOUS SECTIONS WHICH FAILED DUE TO BALLOONING - THAT IS, SWELLING UP ON OPPOSITE SIDE OF THE AREA USED - OF COURSE THIS IS MY DIAGNOSIS OF WHY THE UNIT IS NOT HOLDING UP UNDER YOUR USAGE! ALSO, THE LESSER THE AMOUNT OF INFLATION, THE BETTER. IT DOES NOT REQUIRE MORE THAN ABOUT HALF-INFLATION TO DO THE JOB! ALSO, AVOIDING PROLONGED SITTING WILL HELP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BYE-BYE-DECUBITI MATTRESS OVERLAY PNEUMATIC MATTRESS UNIT IKY KEN MCRIGHT SUPPLIES INC. HS (MATTRESS COMPLETE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other