EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-12 for EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT UNK manufactured by Genzyme Biosurgery (cambridge).

Event Text Entries

[17199353] Multi-system organ failure [multi-organ failure]. Case description: spontaneous report was rec'd on (b)(6) 2012 (add'l info on (b)(6) 2012) from a physician regarding a (b)(6) male pt, initials (b)(6) with thermal burn. The pt's medical history was not provided. On (b)(6) 2012, the pt sustained 46 percent tbsa (total body surface area) burns. On (b)(6) 2012, at 16:05 hrs, the left and right groin biopsies were performed. The pt was on two unspecified topical antimicrobial or antifungal medications and two unspecified systemic antimicrobial or antifungal medication. On (b)(6) 2012, the pt was grafted with 96 grafts of epicel (lot# ee01641). On an unspecified date, the pt experienced multisystem organ failure. On (b)(6) 2012, after being grafted with epicel, the pt died due to multisystem organ failure. Concomitant medications were not provided. The intensity for the event of multisystem organ failure was not provided. The physician did not provide the relationship between epicel and the event of multisystem organ failure.
Patient Sequence No: 1, Text Type: D, B5


[17349468] Mfr's comment: the benefit-risk relationship of epicel is not affected by this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226230-2012-00006
MDR Report Key2791973
Report Source05
Date Received2012-10-12
Date of Report2012-10-03
Date Mfgr Received2012-10-03
Date Added to Maude2012-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactBRUNO MENDEZ
Manufacturer Street675 WEST KENDALL STREET
Manufacturer CityCAMBRIDGE MA 02142
Manufacturer CountryUS
Manufacturer Postal02142
Manufacturer Phone6177686173
Manufacturer G1GENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer Street64 SIDNEY STREET
Manufacturer CityCAMBRIDGE MA 02139
Manufacturer CountryUS
Manufacturer Postal Code02139
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT
Generic NameCULTURED EPIDERMAL AUTOGRAFTS
Product CodeOCE
Date Received2012-10-12
Model NumberUNK
Catalog NumberUNK
Lot NumberEE01641
ID NumberUNK
Device Expiration Date2012-08-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer AddressCAMBRIDGE MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2012-10-12

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