EPICEL

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 2014-11-17 for EPICEL manufactured by Genzyme Biosurgery (cambridge).

Event Text Entries

[5225689] This unsolicited device case from the united states was received on 11/10/2014 from a physician. This case involved a patient (demographics not provided) who experienced suspected multi-system organ failure after grafted with epicel cultured epidermal autografts (epicel). The patient's past drugs, medical history, concomitant medications or concurrent conditions were not reported. On (b)(6) 2014, the patient was grafted with epicel cultured epidermal autografts, once ((dose, formulation, route, indication, expiration date: not reported and batch/lot number - ee01845). It was reported that the patient was grafted with 48 grafts. On (b)(6) 2014, the patient was grafted for a second time with 48 grafts of epical culture epidermal autografts. On an unknown date, the patient experienced suspected multi-system organ failure. On (b)(6) 2014, the patient expired after being grafted twice with epicel cultured epidermal autografts. It was reported that patient passed away due to suspected multi-system organ failure. Action take: unknown. Corrective treatment: unknown. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226230-2014-57057
MDR Report Key4264537
Report Source05
Date Received2014-11-17
Date of Report2014-11-10
Date Mfgr Received2014-11-10
Date Added to Maude2014-11-21
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 FDA0
Event Location0
Manufacturer ContactKRISTEN SHARMA, MD
Manufacturer Street55 CORPORATE DRIVE MAIL STOP: 55D-205A
Manufacturer CityBRIDGEWATER NJ 08807
Manufacturer CountryUS
Manufacturer Postal08807
Manufacturer Phone9089812784
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPICEL
Generic NameCULTURED EPIDERMAL AUTOGRAFTS
Product CodeOCE
Date Received2014-11-17
Lot NumberEE01845
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer AddressCAMBRIDGE MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-11-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.