MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH

Catalog Number	NW1040
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a possible contact allergy reaction in the neurawrap location.The patient possibly needs a new surgery.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The neurawrap was not returned for evaluation; however, samples from same lot/batch retained by manufacturer were evaluated: dhr - lot 7323737 was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection processes that could be related to the reported condition.The fg lot met all in-process inspections and testing requirements as specified in the shop order and related procedures.No quality event was issued for the reported finished good lot.Failure analysis - not possible because the unit was used and therefore will not be returned.No additional information has been received to confirm if the alleged allergy was caused by the use of the neurawrap product.A retain sample visual inspection of lot 7323737: three (3) neurawrap units were visually inspected.Dispenser boxes and trays were in good condition.The sealing area was complete and in good condition.No foreign material was observed.No defects were observed.Root cause - at the moment, no causal relationship between the product and the reported condition can be determined based on the information provided.However, as indicated in the ifu¿s contraindications, the patient may be hypersensitive to bovine derived materials.
Event or Problem Description
N/a.

• Brand Name: NEURAWRAP NERVE PROTECTOR 10MM ID X 4CM LENGTH
• Common Device Name: NEURAWRAP
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20356167
• Report Number: 2648988-2024-00035
• Device Sequence Number: 20625804
• Product Code: JXI
• UDI-Device Identifier: 10381780026402
• UDI-Public: 10381780026402
• Combination Product (Y/N): N
• PMA/510(K) Number: K041620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: NW1040
• Device Lot Number: 7323737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown