BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED MATTRESS

    MDR report key: 303877 · Received November 4, 2000

    Report

    Report Number
    2182305-2000-00018
    Event Type
    Other
    Date Received
    November 4, 2000
    Date of Event
    August 6, 2000
    Report Date
    August 24, 2000
    Manufacturer
    SUNRISE MEDICAL CCG
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED BURNS TO THEIR SIDE OF FACE, FOREARM AND CHEST FROM LYING ON A FLOTATION THERAPY AIR MATRESS. WHEN PT WAS FOUND THE SHEETS, MATTRESS PAD AND BEDDING WAS ALL BUNCHED UP AND THEY WERE LYING DIRECTLY ON THE MATRESS. MFG REP AND DEALER REP WERE UNABLE TO DETERMINE ANY PRODUCT DEFECT. THE PRODUCT WHEN PICKED UP FROM THE HOME BY THE DEALER HAD BEEN ALTERED BY WAY OF THE FILTER BEING CLEANED AFTER THE INJURY. UNKNOWN HOW DIRTY THIS FILTER WAS PRIOR TO THE INJURY, OR IN FACT THAT THIS UNIT COULD HAVE CONDUCTED ENOUGH HEAT TO CAUSE ANY BURNS? IT IS SUSPECTED THAT THE PT'S INJURIES WERE NOT CAUSED BY THE MATTRESS BUT MAYBE AN ALLEGIC REACTION TO SOMETHING THAT WAS USED ON THE MATTRESS FOR CLEANING. {DEALER IS ATTEMPTING TO OBTAIN THE DR'S REPORT SO THAT CO HAS ACCESS TO THE DR'S OPINION REGARDING THE CAUSE OF THE SAID BURNS AND IN FACT IF THERE WAS ANY BURNS, WHAT KIND WERE THEY; REACTION OR HEAT} !

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED MATTRESS BED, FLOTATION THERAPY, POWERED MATTRESS IOQ SUNRISE MEDICAL CCG 350501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other