MAUDE MDR 1899005

MDR report key
1899005
Report number
1226230-2010-00004
Event key
0
Event type
3
Date received
2010-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
EDWARD GILL, MD
Address
675 WEST KENDALL STREET CAMBRIDGE MA 02142 US
Phone
800-800-8007
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFTCULTURED EPIDERMAL AUTOGRAFTSGENZYME BIOSURGERY (CAMBRIDGE)OCEUNKUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-1401. D; 2. O

Event Narratives#

D

Patient 1

PSEUDOMONAS WOUND INFECTION [WOUND INFECTION PSEUDOMONAS], CANDIDA WOUND INFECTION, FUSARIUM SPECIES WOUND INFECTION [WOUND INFECTION FUNGAL], (B)(6), ACINETOBACTER WOUND INFECTION, ESCHERICHIA COLI, (B)(6), KLEBSIELLA, ENTEROBACTER WOUND INF [WOUND INFECTION BACTERIAL], BLISTERING AND SHEARING [BLISTER], PRURITUS AND ITCHING [PRURITUS], CONTRACTURES [MUSCLE CONTRACTURE], DELAYED LOSS OF CULTURED EPITHELIAL AUTOGRAFTS [GRAFT LOSS], SEPSIS [SEPSIS], MULTIORGAN FAILURE [MULTI-ORGAN FAILURE], DEATH [DEATH]. CASE DESCRIPTION: A PUBLISHED ARTICLE IN (B)(6) TITLED "CULTURED EPITHELIAL AUTOGRAFTS FOR COVERAGE OF LARGE BURN WOUNDS IN EIGHTY-EIGHT PTS: THE INDIANA UNIVERSITY EXPERIENCE." JOURNAL OF BURN CARE & RESEARCH 2010; 31:559-568 (SOOD, R., ROGGY, D. ZIEGER, M., BALLEDEUX, J., CHAUDHARI, S., KOUMANIS, D., MIR, H., COHEN, A., KNIPE, C., GABEHART, K., COLEMAN, J.) WAS REC'D ON (B)(6) 2010. A NEW TECHNIQUE FOR COVERAGE OF LARGE BURNS, WHICH BEGINS WITH EARLY TANGENTIAL EXCISION AND COVERAGE WITH CADAVER ALLOGRAFT (A), FOLLOWED BY PLACEMENT OF CULTURED EPITHELIAL AUTOGRAFT (CEA) ONTO AN ALLODERMIS BASE (CEA/A) HAS BEEN USED SINCE 1990. A REVIEW OF PROSPECTIVELY COLLECTED DATA WAS CONDUCTED ON ADULT AND PEDIATRIC PTS GRAFTED WITH CULTURED EPITHELIAL AUTOGRAFT (CEA) FOR DEFINITIVE WOUND COVERAGE (TOTAL BODY SURFACE AREA (TBSA) 28-98%). THIS SERIES DOCUMENTED THE OUTCOMES OF 88 PTS (20 CHILDREN AND 68 ADULTS) WITH LARGE BURNS THAT WERE TREATED WITH THE CEA/A TECHNIQUE OVER AN 18-YEAR PERIOD, FROM 1990-2008. THE AGE RANGE OF THIS PT POPULATION WAS FROM (B)(6), WITH A MEAN OF (B)(6). THE TBSA BURNED IN THIS STUDY GROUP RANGED FROM 28 TO 98%, WITH A MEAN OF 58.5%. THE TBSA OF FULL-THICKNESS BURNS RANGED FROM 0 TO 94%, WITH A MEAN OF 51.2%. THE MECHANISM OF BURN INJURIES WERE FLAME (N=78), SCALD (N=9), AND CHEMICAL (N=1). THE MEAN ABBREVIATED BURN SEVERITY INDEX WAS 9.69. THE OVERALL SURVIVAL RATE IN THIS STUDY GROUP WAS 91% (80 OF 88% PTS). THE MAJORITY OF ADULT PTS (DEFINED AS OLDER THAN 18 YRS) HAD PRE HOSPITAL COMORBIDITIES INCLUDING: TOBACCO USE, ETHANOL ABUSE, DRUG ABUSE, HYPERTENSION, ASTHMA, ARRHYTHMIA, (B)(6), NEUROLOGIC, FACTOR VII DEFICIENCY, NON-INSULIN-DEPENDENT DIABETES MELLITUS AND RENAL FAILURE. PTS WENT TO THE OPERATING ROOM AN AVERAGE OF 9 TIMES. THE AVERAGE NUMBER OF OPERATIONS FOR ALLOGRAFT MAINTENANCE WAS 4.9, WITH A MEAN OF 20.1 SQUARE FEET OF ALLOGRAFT USED (ALLOGRAFTS USAGE DATA WAS UNAVAILABLE FOR SIX PTS). THE MEAN TIME TO CEA PLACEMENT WAS 30.6 DAYS. THE MEAN TBSA COVERED WITH AUTOGRAFTS WAS 25.6%, WHEREAS THE MEAN TBSA COVERED WITH CEA/A TECHNIQUE WAS 31.2%. THE TAKE OF CEA WAS DEFINED AS THE PERCENT BODY SURFACE AREA (BSA) WITH PERMANENT COVERAGE BY THE CEA/A TECHNIQUE NOT REQUIRING REGRAFTING OR ANY OTHER FORMS OF COVERAGE. THE AVERAGE TAKE OF CEA SHEETS TO THE UNDERLYING ALLODERMIS WAS 72.1% AFTER 1 WEEK AND 67.4% AT 21 DAYS POSTOPERATIVE. AT THE TIME OF DISCHARGE, THE AVERAGE FINAL TAKE RATE FOR 88 PTS WAS 72.7%. IN STRATIFYING PTS TO "LARGE" (>50% TBSA; N=64) OR "SMALL" (