MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-04-10 for NEUROMEND CNW4025 manufactured by Collagen Matrix, Inc..
[141500878]
Review of the production records confirmed that the product met release criteria. Additional inspection and testing of the reserve samples was found to be conforming and met release criteria. Product testing did not re-produce the "horse shoe" shape non-conformance observed by the clinician. The product instructions for use indicate that "if there is no overlap and edges are approximated, the slit may be closed with a running suture".
Patient Sequence No: 1, Text Type: N, H10
[141500879]
It was reported by the clinician that during the nerve repair procedure, the product would not wrap together as intended and would only form a "horse shoe" shape. The clinician decided to use another product and the procedure was successfully completed with a 15-20 minute surgical delay. No further information is available due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2019-00010 |
| MDR Report Key | 8500782 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-10 |
| 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 | MS. GLORIA ZUCLICH |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Manufacturer G1 | COLLAGEN MATRIX, INC. |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROMEND |
| Generic Name | COLLAGEN NERVE WRAP |
| Product Code | JXI |
| Date Received | 2019-04-10 |
| Model Number | CNW4025 |
| Lot Number | 1801182032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | 15 THORNTON ROAD OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-10 |