BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 3466880 · Received November 5, 2013

    Report

    Report Number
    1226230-2013-10660
    Event Type
    Death
    Date Received
    November 5, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    GENZYME BIOSURGERY (CAMBRIDGE)
    Product Code
    OCE
    PMA / PMN Number
    HDE 990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES RECEIVED ON (B)(4) 2013 FROM A NON-HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A PT (DEMOGRAPHICS UNK) WHO DIED AFTER GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PT'S MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION OR CONCURRENT CONDITION WAS NOT REPORTED. ON (B)(6) 2013, THE PT WAS GRAFTED WITH 110 GRAFTS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER EE01736 AND EXPIRATION DATE UNK) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2013 (35 DAYS FOLLOWING GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS), THE PT DIED DUE TO AN UNREPORTED CAUSE. NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: FATAL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER OF (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569455 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE GENZYME BIOSURGERY (CAMBRIDGE) EE01736

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CON MEDS = UNK| PREV MEDS = UNK