BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 3564056 · Received January 6, 2014

    Report

    Report Number
    1226230-2013-29919
    Event Type
    Death
    Date Received
    January 6, 2014
    Date of Event
    January 17, 2013
    Report Date
    December 10, 2013
    Manufacturer
    GENZYME BIOSURGERY (CAMBRIDGE)
    Product Code
    OCE
    PMA / PMN Number
    H990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 PT (DEMOGRAPHICS UNSPECIFIED) WHO EXPIRED AFTER GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2012, THE PT WAS GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER (B)(4) AND EXPIRATION DATE UNKNOWN) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2013 (51 DAYS FOLLOWING GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFT), THE PT EXPIRED DUE TO AN UNREPORTED CAUSE. CORRECTIVE TREATMENT: UNKNOWN. OUTCOME: FATAL. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8155 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE GENZYME BIOSURGERY (CAMBRIDGE) EE01624

    Patients

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