BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT

    MDR report key: 2850964 · Received November 21, 2012

    Report

    Report Number
    1226230-2012-00008
    Event Type
    Death
    Date Received
    November 21, 2012
    Report Date
    November 11, 2012
    Manufacturer
    GENZYME BIOSURGERY (CAMBRIDGE)
    Product Code
    OCE
    PMA / PMN Number
    HDE 990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF EPICEL IS NOT AFFECTED BY THIS CASE.

    Description of Event or Problem · 1

    EMBOLISM [EMBOLISM]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A NURSE VIA SALES REPRESENTATIVE REGARDING A FEMALE PATIENT (INITIALS AND AGE NOT PROVIDED) WITH THERMAL BURN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT WAS GRAFTED WITH 144 GRAFTS OF EPICEL (#(B)(4)) AT HOSPITAL. IT WAS REPORTED THAT INITIALLY THE PATIENT'S GRAFT UPTAKE WAS 80%, WHICH DEVELOPED AND HELD WELL ONE MONTH POST-GRAFTING. THE PATIENT WAS EATING NORMAL FOOD AND WAS IN GOOD SPIRITS. IT WAS REPORTED THAT, AS THE NURSING STAFF BEGAN TO AMBULATE, THE PATIENT COLLAPSED POSSIBLY FROM AN EMBOLISM AND DIED ON (B)(6) 2012. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS SEVERE. THE REPORTING NURSE DID NOT PROVIDE ANY CAUSAL RELATIONSHIP BETWEEN EPICEL AND THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT CULTURED EPIDERMAL AUTOGRAFTS OCE GENZYME BIOSURGERY (CAMBRIDGE) UNK EE01638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death