FDA Adverse Event Summary report: N

EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT

MDR report key: 1063736 · Received June 20, 2008

Report

Report Number
1226230-2008-00009
Date Received
June 20, 2008
Report Date
June 15, 2008
Manufacturer
GENZYME BIOSURGERY (CAMBRIDGE)
Product Code
MGR
PMA / PMN Number
HUD 98-0027
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

MULTI-SYS ORGAN FAILURE [MULTI-ORGAN FAILURE]. CASE DESCRIPTION. SPONTANEOUS REPORT RECEIVED ON 06/15/2008 FROM A CO REP REGARDING A MALE PT, (B) (6), WHO HAD A RELEVANT MEDICAL HISTORY OF A THERMAL BURN. THE PT WAS GRAFTED TWICE WITH EPICEL: 130 GRAFTS ON (B) (6) 2008 AND 40 GRAFTS ON (B) (6) 2008. ON (B) (6) 2008, THE PT DIED DUE TO MULTI-SYS ORGAN FAILURE. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS FATAL ON (B) (6) 2008. THE PT'S BIOPSY REPORT WAS OBTAINED ON (B) (6) 2008. THE PT WAS A (B) (6) MALE, (B) (6), WHO EXPERIENCED A THERMAL BURN ON (B) (6) 2008, IN WHICH 95% OF HIS TOTAL BODY SURFACE AREA (TBSA) WAS INJURED: 90% TBSA FULL THICKNESS BURNS AND 5% TBSA PARTIAL THICKNESS BURNS. ON (B) (6) 2008, THE PT WAS ADMITTED TO THE HOSPITAL'S BURN UNIT AND WAS BIOPSIED AT 14:05. THE BIOPSY SITE OF TUBE 1 WAS THE LEFT LOWER ABDOMEN AND THE BIOPSY SITE OF TUBE 2 WAS THE RIGHT UPPER THIGH (EXPIRATION DATE ON TUBES: 04/30/2008). AT THE TIME OF THE BIOPSY, THE PT DID NOT HAVE ANY MICROBIAL OR FUNGAL WOUND OR SYSTEMIC INFECTIONS. CURRENT MEDICATIONS INCLUDED: SULFAMYLON CREAM. ADD'L' INFO WAS RECEIVED ON 06/17/2008 FROM A CO REP. THE PT RECEIVED EPICEL LOT #: EE01167. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS FATAL ON (B) (6) 2008.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT CULTURED EPIDERMAL AUTOGRAFTS MGR GENZYME BIOSURGERY (CAMBRIDGE) UNK EE01167

Patients

Seq Age Sex Outcome Treatment
1 23 YR Death