BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 3535579 · Received December 12, 2013

    Report

    Report Number
    1226230-2013-27690
    Event Type
    Death
    Date Received
    December 12, 2013
    Date of Event
    October 28, 2013
    Report Date
    December 6, 2013
    Manufacturer
    GENZYME BIOSURGERY (CAMBRIDGE)
    Product Code
    OCE
    PMA / PMN Number
    HDE990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES RECEIVED ON (B)(6) 2013 FROM A NON-HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A PATIENT WHO DIED (DEMOGRAPHICS UNSPECIFIED) AFTER GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE IN 2013, THE PATIENT WAS GRAFTED WITH 110 GRAFTS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER EE01736 AND EXPIRATION DATE UNKNOWN) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2013 (35 DAYS FOLLOWING GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS), THE PATIENT DIED DUE TO AN UNREPORTED CAUSE. CORRECTIVE TREATMENT: UNKNOWN. OUTCOME: FATAL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND CONCLUSIONS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650067 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE GENZYME BIOSURGERY (CAMBRIDGE) EE01736

    Patients

    Seq Age Sex Outcome Treatment
    1 Death