BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL

    MDR report key: 4245041 · Received November 6, 2014

    Report

    Report Number
    1226230-2014-51721
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    February 22, 2016
    Report Date
    December 30, 2016
    Manufacturer
    VERICEL CORPORATION LIZ BICCHIERI
    Product Code
    OCE
    PMA / PMN Number
    HDE 990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON OCTOBER 30, 2014 FROM A NURSE. THIS CASE INVOLVES A PATIENT (UNKNOWN DEMOGRAPHICS) WHO EXPIRED AFTER GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). THE PATIENT'S PREVIOUS MEDICATION, MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE NOT REPORTED. ON (B)(6) 2014, THE PATIENT WAS GRAFTED WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (DOSE, FORMULATION, ROUTE, FREQUENCY, INDICATION, EXPIRATION DATE: NOT REPORTED AND BATCH/LOT NUMBER - EE01792). IT WAS REPORTED THAT THE PATIENT WAS GRAFTED WITH 48 GRAFTS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS. ON (B)(6) 2014, THE PATIENT EXPIRED (CAUSE OF DEATH UNK). IT WAS UNKNOWN IF AUTOPSY WAS DONE. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (B)(4) AND RESULTS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714252 EPICEL CULTURED EPIDERMAL AUTOGRAFTS OCE VERICEL CORPORATION LIZ BICCHIERI EE01792

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| H PREV MEDS = UNK| CON MEDS = UNK