BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 3677061 · Received February 25, 2014

    Report

    Report Number
    1226230-2014-20952
    Event Type
    Death
    Date Received
    February 25, 2014
    Date of Event
    January 17, 2013
    Report Date
    February 14, 2014
    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)(4) 2014 FROM A NON-HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A PT (UNSPECIFIED DEMOGRAPHICS) WHO EXPIRED DUE TO UNREPORTED CAUSE AFTER GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO PAST MEDICATIONS, MEDICAL HISTORY, OR CONCURRENT CONDITIONS AND CONCOMITANT CONDITIONS WERE REPORTED. AN UNK DATE IN 2012, THE PT WAS GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE101624 AND EXPIRATION DATE: UNK) ON AN UNSPECIFIED LOCATION FOR THERMAL BURNS. ON (B)(6) 2013, (51 DAYS FOLLOWING GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS), THE PT EXPIRED DUE TO AN UNREPORTED CAUSE. CORRECTIVE TREATMENT: NOT REPORTED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND CONCLUSION WAS PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114913 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE GENZYME BIOSURGERY (CAMBRIDGE) EE101624

    Patients

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