BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCURY MEDICAL

    MDR report key: 1075376 · Received July 9, 2008

    Report

    Report Number
    1024404-2008-00003
    Event Type
    Injury
    Date Received
    July 9, 2008
    Report Date
    July 7, 2008
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED; THEREFORE, MFR CAN NOT CONFIRM THAT IT IS MERCURY MEDICAL PRODUCT. MFR CAN NOT CONFIRM ALLERGIC REACTION WAS CAUSED BY THE PRODUCT. DEVICE HISTORY RECORDS FOR ALL MERCURY MEDICAL ANESTHESIA CIRCUITS (MAPLESON) PRODUCTS SOLD TO HOSP WERE REVIEWED AND FOUND TO BE MFG TO SPECIFICATIONS. PROD AND PACKAGING IS LATEX FREE.

    Description of Event or Problem · 1

    #1 RN FEMALE STAFF WAS LEADING A CLASS AND OPENED THE PACKAGE TO DEMONSTRATE THE PRODUCT. IMMEDIATELY AFTER OPENING THE PACKAGE SHE FELT A "TICKLE IN HER THROAT" SX WORSENED QUICKLY AFTER HANDLING THE BAG. SHE BECAME SHORT OF BREATH, COUGHING, AND AUDIBLE WHEEZING. SHE WAS TREATED WITH EPINEPHRINE, PREDNISONE AND 3 RESPIRATORY TREATMENTS BEFORE CONTROL WAS REGAINED. KNOWN ANAPHYLACTIC REACTIONS TO FLOOR CLEANER AND RUG CLEANER AND SOME HOUSEHOLD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCURY MEDICAL ANESTHESIA CIRCUIT (MAPLESON) CAI 1080350 OR 1080351

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention