BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHILDREN'S MEDICAL VENTURE

    MDR report key: 1463313 · Received August 25, 2009

    Report

    Report Number
    MW5012570
    Event Type
    Malfunction
    Date Received
    August 25, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 19, 2009
    Manufacturer
    RESPIRONICS
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CLINICAL NURSING INSTRUCTOR (VISITOR), WHILE IN THE PROCESS OF ACTIVATING THE HEEL SNUGGLER FOR USE - BAG EXPLODED AND WATERY CONTENTS GOT ON VISITOR'S CHEST, NECK, FACE AND HAIR (HAD ON EYEGLASSES). VISITOR WAS TREATED IN EYE STATION (DENIED GETTING CONTENTS IN EYES), AND PROVIDED FULL BODY SHOWER. VISITOR CONVEYED SHE HAS HAD "NO CHANGES IN SKIN COLOR" OR OTHER COMPLAINTS AS RESULT OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDREN'S MEDICAL VENTURE HEEL SNUGGLER MPO RESPIRONICS 072109

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other