MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-30 for NEURAGEN NERVE GUIDE 4MM ID X 3CM LENGTH PNG430 manufactured by Integra Lifesciences Corporation.
[32348661]
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 1093539 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 08/07/2009. 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, (b)(4) 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 repair 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
[32348662]
Retrospective review of collagen products from 2009-present indicate that an mdr should have been filed based on the reporter's information. It was reported the patient developed inflammation postoperatively, following a procedure where the product had been implanted. A (b)(6) female patient underwent carpal tunnel release 're-do' procedure on (b)(6) 2009. On (b)(6) 2010 the physician called integra reporting postoperative inflammation. He left a voicemail message requesting product information; ' the patient may have had some reaction to it. ' it was reported the product was cut in half and wrapped around the nerve. No other products were used. The patient had symptoms of swelling at the base of her thumb and along the incision. Cytology was sent - only inflammatory cells were identified, no infection. The physician was asking for information on allergy or inflammatory response. It was later reported during a phone call with the physician, 'he used the product by cutting it in half lengthways and realized he had used off label. '
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2015-00028 |
| MDR Report Key | 5255974 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-30 |
| Date of Report | 2010-01-21 |
| Date of Event | 2010-01-21 |
| Date Mfgr Received | 2015-11-30 |
| Device Manufacturer Date | 2009-08-22 |
| Date Added to Maude | 2015-11-30 |
| 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 | NEURAGEN NERVE GUIDE 4MM ID X 3CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2015-11-30 |
| Catalog Number | PNG430 |
| Lot Number | 1093539 |
| 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. Other | 2015-11-30 |