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 2018-07-17 for NEUROWRAP PROTECTOR XXX-NEUROWRAP manufactured by Integra Lifesciences Corporation.
[114158635]
The complaint product was not returned for evaluation. No dhr was reviewed as no lot number provided. Failure analysis unconfirmed; root cause undetermined as no product was returned.
Patient Sequence No: 1, Text Type: N, H10
[114158636]
It was reported by a sales representative that a patient rejected a neurawrap protector implant, requiring a revision surgery. No patient injury reported. No additional information was provided after several attempts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00032 |
| MDR Report Key | 7693732 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-17 |
| Date of Report | 2018-06-22 |
| Date Mfgr Received | 2018-06-22 |
| Date Added to Maude | 2018-07-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| 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 | NEUROWRAP PROTECTOR |
| Generic Name | NEUROWRAP |
| Product Code | JXI |
| Date Received | 2018-07-17 |
| Catalog Number | XXX-NEUROWRAP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-07-17 |