BEUDAMED
    FDA Adverse Event Summary report: N

    GLOBAL HEALTHCARE MATTRESS SHEET

    MDR report key: 1942490 · Received November 23, 2010

    Report

    Report Number
    3004635124-2010-00001
    Date Received
    November 23, 2010
    Date of Event
    October 2, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GLOBAL HEALTHCARE
    Product Code
    KME
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2010, (B)(6) WAS CONTACTED VIA PHONE BY MS. (B)(6), AN EMPLOYEE OF HOSPITAL (B)(6) ADVISING THAT ON (B)(6), 2010, A (B)(6) FEMALE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH A HIGH FEVER AND AFTER LYING ON A MATTRESS COVERED BY A FITTED SHEET SUPPLIED BY (B)(6), SHE DEVELOPED DERMATITIS. THE SYMPTOMS WERE DESCRIBED AS "FIRST AND SECOND DEGREE BURNS". (B)(6) LAUNCHED AN INVESTIGATION OF THE INCIDENT; HOWEVER, DESPITE REPEATED REQUESTS TO THE COMPLAINANT HOSPITAL, (B)(6) HAS BEEN PROVIDED WITH LITTLE FURTHER INFO. ON (B)(6), 2010, OUR DISTRIBUTOR IN (B)(4) WAS ABLE TO PROVIDE US WITH LOT NUMBERS FOR THE PRODUCTS AND SAMPLE SHEETS FROM THE LOTS. THIS INFO IS BEING USED TO INVESTIGATE THE INCIDENT WITH THE CONTRACT MFR OF THE PRODUCT. TO DATE, (B)(6) HAS RECEIVED NO FURTHER INFO REGARDING THE PT, HER IDENTIFICATION OR ANY RECORDS RELATING TO THE DIAGNOSIS, TREATMENT OR CONDITION OF THE PT TO HELP ASCERTAIN WHETHER THE CONDITION MAY HAVE BEEN CAUSED BY THE FITTED SHEET. THE INVESTIGATION REMAINS ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL HEALTHCARE MATTRESS SHEET KME GLOBAL HEALTHCARE 41-MS2 PO114-10/PO225-10

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Hospitalization