MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-09 for NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NW740 manufactured by Integra Lifesciences Corporation.
[33098560]
Integra has completed their internal investigation. The investigation activities included: methods: review of device history records. Review of complaint history. Results: the device history record (dhr) of lot 1093935 was reviewed and showed no anomalies during the manufacturing process of the device. This lot was sent to be sterilized to steri-tech facility on (b)(6) 2009. All in-process and release criteria were acceptable. No similar complaints have been recorded for lot 1093539. Upon reviewing the complaint system over the last two years, two (2) similar complaints related with? Inflammation" have been reported since 2008. During this timeframe, approximately (b)(4) units of neuragen family have been shipped resulting in a complaint occurrence rate of approximately (b)(4). Conclusion: based on the investigation findings, no assignable cause and/ or anomalies associated at manufacturing process of the product which could contribute and/ or be related with reported incident were identified. The cause for the reported incident could not be determined at this time. Package insert establishes in the adverse events section: "possible complications can occur with any nerve surgical procedure including pain, infection, decreased or increased nerve sensitivity, and complications associated with the use of anesthesia. "
Patient Sequence No: 1, Text Type: N, H10
[33098561]
Retrospective review of collagen products from 2009-present indicate that an mdr should have been filed based on the reporters information. It was reported the physician questioned an association between postoperative symptoms of swelling and nausea, and an allergic reaction to the product. The physician reported using the product in a patient several weeks prior to the date of the phone call. The patient had nausea and swelling in her hand. No infection isolated from cultures. The physician asked about allergic reactions with use of the product. "the patient underwent a left wrist carpal tunnel revision on (b)(6) 2009. No other implants were used. Cultures were negative. The patient had a history of chronic back pain controlled with nerve stimulator. Her postoperative history indicates she gradually developed increasing swelling and worsening pain in her wrist with redness but no streaking. She has been nauseated but has not had fever above 100 (degrees). The patient's provider reported that with the culture and lab results available they could not prove an infection. " the reporting physician stated, " i have not seen the patient myself but am told the swelling is worsening slowly. She (the patient) received vicodin post operatively and then cipro when the swelling started around christmas time. No labs were drawn when she started cipro. Labs were drawn (b)(6) and her sed rate was 12 with a normal cbc with diff. She is not on antibiotics now. She was not hospitalized after her surgery. We are scheduling her to return to (b)(6) for evaluation but are not planning on re-hospitalization at this time. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2015-00030 |
| MDR Report Key | 5278658 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-09 |
| Date of Report | 2010-01-20 |
| Date of Event | 2009-11-25 |
| Date Mfgr Received | 2015-12-03 |
| Device Manufacturer Date | 2009-09-04 |
| Date Added to Maude | 2015-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2015-12-09 |
| Catalog Number | NW740 |
| Lot Number | 1093935 |
| Device Expiration Date | 2011-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-09 |