EPICEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-01-06 for EPICEL manufactured by Genzyme Biosurgery (cambridge).

Event Text Entries

[4050205] This unsolicited device case from united states received on (b)(6) 2013 from a non-healthcare professional. This case concerns a pt (demographics unspecified) who expired after grafting with epicel cultured epidermal autografts (epicel). No past drugs, medical history, concurrent conditions or concomitant medications were reported. On (b)(6) 2012, the pt was grafted with epicel cultured epidermal autografts (batch/lot number (b)(4) and expiration date unknown) on an unspecified location for thermal burn. On (b)(6) 2013 (51 days following grafting with epicel cultured epidermal autograft), the pt expired due to an unreported cause. Corrective treatment: unknown. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and conclusion was pending for the same.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226230-2013-29919
MDR Report Key3564056
Report Source04
Date Received2014-01-06
Date of Report2013-12-10
Date of Event2013-01-17
Date Mfgr Received2013-12-10
Date Added to Maude2014-01-10
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 Street55 CORPORATE DRIVE MAIL STOP: 55D-205A
Manufacturer CityBRIDGEWATER NJ 08807
Manufacturer CountryUS
Manufacturer Postal08807
Manufacturer Phone9089816698
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEPICEL
Generic NameCULTURED EPIDERMAL AUTOGRAFTS
Product CodeOCE
Date Received2014-01-06
Lot NumberEE01624
OperatorOTHER
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENZYME BIOSURGERY (CAMBRIDGE)
Manufacturer AddressCAMBRIDGE MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-01-06

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