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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH
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INTEGRA LIFESCIENCES CORP. NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH Back to Search Results
Catalog Number PNG330
Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2014
Event Type  Other  
Event Description
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.
 
Manufacturer Narrative
The device involved in the reported incident is not available for eval.An investigation has been initiated based on the reported info.
 
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Brand Name
NEURAGEN NERVE GUIDE 3MM ID X 3CM LEENGTH
Type of Device
NEURAGEN
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORP.
plainsboro NJ 08536
Manufacturer Contact
caren finkelstein
315 enterprise dr
plainsboro, NJ 08536
6099362341
MDR Report Key3844653
MDR Text Key16778865
Report Number1121308-2014-00015
Device Sequence Number1
Product Code JXI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2013
Device Catalogue NumberPNG330
Device Lot Number1115140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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