FDA.reportPublic FDA data

MAUDE MDR 3535578

MDR report key
3535578
Report number
1226230-2013-28598
Event key
0
Event type
3
Date received
2013-12-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
55 CORPORATE DRIVE MAIL STOP: 55D-205A BRIDGEWATE NJ 08807 US
Phone
908-908-9089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EPICELCULTURED EPIDERMAL AUTOGRAPHSGENZYME BIOSURGERY (CAMBRIDGE)OCEEE01741*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-12-1201. D; 2. O

Event Narratives#

D

Patient 1

THIS UNSOLICITED DEVICE CASE FROM UNITED STATES RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN. THIS CASE CONCERNS A PATIENT (DEMOGRAPHICS NOT PROVIDED) WHO HAD SOME METABOLIC DISTURBANCES, SUFFERED FROM (03) STROKES AND PATIENT PASSED AWAY AFTER RECEIVING EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). RELEVANT MEDICAL HISTORY, CONCOMITANT CONDITIONS OR MEDICATIONS WERE NOT PROVIDED. ON (B)(6) (YEAR UNSPECIFIED), THE PATIENT RECEIVED EPICEL CULTURED EPIDERMAL AUTOGRAFTS (ROUTE, DOSAGE REGIMEN, BATCH/LOT NUMBER : (B)(4) AND EXPIRATION DATE UNKNOWN) INTO AN UNSPECIFIED LOCATION FOR THERMAL BURNS. ON AN UNSPECIFIED DATE, THE PATIENT PASSED AWAY DUE TO UNREPORTED CAUSE. IT WAS REPORTED THAT THE PATIENT WAS ESSENTIALLY HEALED AND WAS BEING WORKED FOR SOME RECONSTRUCTION AND TOUCH UP GRAFTING. ON AN UNSPECIFIED DATE, MAGNETIC RESONANCE IMAGING (MRI) SHOWED THAT THE PATIENT HAD 03 STROKES AND HAD SOME METABOLIC DISTURBANCES. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN FOR THE EVENTS OF SOME METABOLIC DISTURBANCES AND SUFFERED FROM 03 STROKES. FATAL FOR THE EVENT OF PASSED AWAY. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: SUFFERED FROM 03 STROKES: IMPORTANT MEDICAL EVENT AS PER IME LIST. PASSED AWAY: PATIENT DIED.

N

Patient 1

PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2013: IN THIS CASE, THE CAUSAL ROLE OF THE EPICEL CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT OF STROKE AND THE FATAL EVENT OF DEATH NOS; HOWEVER, THE LACK OF INFORMATION REGARDING THE UNDERLYING MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS USED BY THE PATIENT PRECLUDES THE COMPLETE CASE ASSESSMENT, AND MOREOVER THE LACK OF INFORMATION REGARDING THE AUTOPSY FINDINGS OF THE PATIENT AND THE FURTHER INFORMATION LACK REGARDING THE AUTOPSY DETAILS PRECLUDES THE COMPLETE CASE ASSESSMENT. INITIAL REPORTER: (B)(6).