NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH PNG330

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-05-07 for NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH PNG330 manufactured by Integra Lifesciences Corp..

Event Text Entries

[16778865] It was reported expired neuragen was implanted during nerve repair hand surgery on (b)(6) 2014. There was no adverse consequences to the pt reported to date.
Patient Sequence No: 1, Text Type: D, B5


[16940699] The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2014-00015
MDR Report Key3844653
Report Source06,07
Date Received2014-05-07
Date of Report2014-04-16
Date of Event2014-04-14
Date Mfgr Received2014-04-16
Date Added to Maude2014-06-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCAREN FINKELSTEIN
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH
Generic NameNEURAGEN
Product CodeJXI
Date Received2014-05-07
Catalog NumberPNG330
Lot Number1115140
Device Expiration Date2013-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP.
Manufacturer AddressPLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-05-07

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