BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUR MED PRESSURE REDUCING PRODUCT

    MDR report key: 2557908 · Received April 26, 2012

    Report

    Report Number
    2557908
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 26, 2012
    Manufacturer
    TEMPUR MED
    Product Code
    FMW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE DISCOVERED IN TWO (2) DIFFERENT DEPARTMENTS IN THE FACILITY BLOOD & MOLD STAINS ON THE CUSHIONS THAT ARE WITHIN AN IMPERMEABLE COVER. THE CUSHION AND COVER ARE MANUFACTURED BY ONE COMPANY BUT SOLD BY ANOTHER COMPANY AS PART OF THEIR PROCEDURE TABLE FOR THE INTERVENTIONAL RADIOLOGY DEPARTMENT AND ENDOVASCULAR LAB.======================MANUFACTURER RESPONSE FOR MATTRESS TABLETOP-WIDE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================MANUFACTUER'S REP WAS PRESENT ONCE WE DISCOVERED THE MOLD AND BLOOD STAINS ON CUSHION. PERFORATIONS IN THE CUSHION COVER COULD NOT BE DETECTED, LEAKS APPEARED TO HAVE COME FROM SEAMS. MANUFACTURER'S REP MAKING ARRANGEMENTS TO TAKE PRODUCT FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPUR MED PRESSURE REDUCING PRODUCT MATTRESS TABLETOP-WIDE FMW TEMPUR MED * *
    2 PRESSURE REDISTRIBUTING PRODUCT MATTRESS TABLETOP- WIDE FMW TEMPUR MED * *
    3 * MATTRESS TABLETOP-WIDE FMW TEMPURMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *