NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NW740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-02 for NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NW740 manufactured by Integra Lifesciences Corp..

Event Text Entries

[3894511] It was reported a pt presented with reactions potentially due to neurawrap following revision carpal tunnel and cubital tunnel surgery. Additional info was reported by the surgeon: "the pt experienced pain in the carpal tunnel area, as well as the wrist post surgery. She presented at two weeks post-surgery with inflamed skin over the cubital tunnel that looked as if it was an "abscess. " a small incision was made and the implant looked as though it had just been placed. No odor and no pus. The extruded material was described as grey gelatinous material just like that found in a rheumatoid joint. The pt responded to the steroid treatment and the small exploratory incision at the wrist, is closing well. The pt currently has a lump over the wrap used in the elbow. The surgeon reported this as reactive synovitis" and has decided not to remove the implants. He said he will wait and see if the problem resolves with the steroid treatment.
Patient Sequence No: 1, Text Type: D, B5


[10908243] The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1121308-2013-00044
MDR Report Key3284628
Report Source05,07
Date Received2013-08-02
Date of Report2013-08-02
Date Mfgr Received2013-07-10
Date Added to Maude2013-08-26
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 DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362341
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH
Generic NameNEURAWRAP
Product CodeJXI
Date Received2013-08-02
Catalog NumberNW740
Lot Number1121702
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP.
Manufacturer AddressPLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-08-02

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