BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRESS SHEETS (DISPOSABLE), 46' X 84"

    MDR report key: 1905768 · Received November 16, 2010

    Report

    Report Number
    MW5018248
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 14, 2010
    Manufacturer
    GLOBAL HEALTHCARE
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CAME TO THE EMERGENCY ROOM. PLACED ON A CRIB WITH A DISPOSABLE FITTED SHEET. PT WAS LAYING ON HER RIGHT SIDE AND PRESENTS A 1ST DEGREE BURN. SKIN BIOPSY WAS REQUIRED. DATES OF USE: (B)(6), 2009. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATTRESS SHEETS (DISPOSABLE), 46' X 84" KME GLOBAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Hospitalization| R