BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPICEL

    MDR report key: 1898995 · Received October 14, 2010

    Report

    Report Number
    1226230-2010-00003
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    October 4, 2010
    Manufacturer
    VERICEL CORPORATION
    Product Code
    OCE
    PMA / PMN Number
    HDE 990002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE (B)(4) FOR OTHER EVENTS FROM THIS REPORTER. UPON ADDITIONAL REVIEW ON 18-OCT-2010, THE COMPANY CAUSALITY FOR SCAR CONTRACTURES, POSTOPERATIVE PNEUMONIA, URINARY TRACT INFECTION AND CEA LOSS WAS CHANGED FROM POSSIBLE TO UNRELATED.

    Description of Event or Problem · 1

    CASE DESCRIPTION: NARRATIVE: A PUBLISHED ARTICLE IN THE UNITED STATES TITLED "COVERAGE OF LARGE PEDIATRIC WOUNDS WITH CULTURED EPITHELIAL AUTOGRAFTS IN CONGENITAL NEVI AND BURNS: RESULTS AND TECHNIQUE." JOURNAL OF BURN CARE & RESEARCH 2009; VOLUME 30, NUMBER 4: 576-86 (SOOD, R., BALLEDUX, J., KOUMANIS, D., MIR, H., CHAUDHARI, S., ROGGY, D., ZIEGER, M., COHEN, A., AND COLEMAN, J.) WAS RECEIVED ON 04-OCT-2010. A RETROSPECTIVE SINGLE INSTITUTION REVIEW WAS DONE FOR 29 CHILDREN (20 BURNS AND 9 PATIENTS WITH GIANT CONGENITAL NEVI (GCN)) WHO UNDERWENT COVERAGE OF THEIR LARGE SURFACE AREA WOUNDS WITH CULTURED EPITHELIAL AUTOGRAFTS (CEA) OVER AN 18-YEAR PERIOD. EXCELLENT TAKE RATES WERE NOTED; 76.4% FOR BURN PATIENTS AND 66% FOR PATIENTS WITH GCN. ALL OF THE PATIENTS IN THE STUDY GROUP SURVIVED. IN THE GCN GROUP, THE FINAL TAKE OF CEA WAS 80% IN SIX OF NINE PATIENTS. HOWEVER, IN FIVE OF NINE PATIENTS, THERE WAS 80% OR GREATER CULTURED SKIN TAKE. COMPLICATIONS OF THIS TREATMENT OF GCN INCLUDED SCAR CONTRACTURES IN TWO OF NINE PATIENTS, ONE REQUIRING SURGICAL RELEASE, ONE OF NINE PATIENTS SUFFERED A POSTOPERATIVE PNEUMONIA NECESSITATING PROLONGED INTUBATION AND TWO PATIENTS WERE TREATED FOR URINARY TRACT INFECTIONS. AVERAGE LENGTH OF FOLLOW-UP WAS 14 YEARS. IN THE GCN PATIENTS, OVERALL TAKE WAS 66%. LOSSES OF CEA OCCURRED EARLY IN THEIR EXPERIENCE RELATED MOSTLY TO UNFAMILIARITY OF TECHNIQUE AND THE FRAGILITY OF THE CULTURED KERATINOCYTES. IN THE LATER CASES, TAKE RATES ABOVE 90% WERE REGULARLY ACHIEVED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENTS ADVERSE EVENTS WAS UNKNOWN. THIS LITERATURE ARTICLE WAS REVIEWED BY THE GENZYME GLOBAL SAFETY OFFICER (GSO) ON AN UNSPECIFIED DATE IN AUGUST 2009. ON 19-AUG-2009, THE GSO SPOKE WITH DR. (B)(6) WHO CONFIRMED THE EVENTS WERE NOT RELATED TO EPICEL, BUT RATHER WERE NORMAL COMPLICATIONS IN BURN PATIENTS. PER THE LITERATURE SOP IN AUGUST 2009, A CASE WAS NOT CREATED BECAUSE AT THAT TIME LITERATURE CASES WERE CREATED BASED ON RELATION. ON 04-OCT-2010, THIS LITERATURE ARTICLE WAS RE-REVIEWED AND THIS CASE WAS CREATED AS A RESULT OF THE NEW LITERATURE SOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICEL CULTURED EPIDURAL AUTOGRAFTS OCE VERICEL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1