MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for NEUROMEND manufactured by Collagen Matrix, Inc..
[53937402]
The implant and explant dates could not be obtained/verified by collagen matrix, inc. From the physician and/or sales representative, therefore product stability could not be evaluated and compared with the product design specifications. Additionally, collagen matrix, inc. Could not obtain product traceability information (i. E. Lot number, product reference number, udi) during initial and follow-up communications, preventing the company from performing any follow-up evaluations or product testing. No similar incidents have been reported to collagen matrix, inc. For this product to date.
Patient Sequence No: 1, Text Type: N, H10
[53937403]
Clinician reported that the neuromend tube was not absorbed and required a second procedure to remove the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2016-00014 |
| MDR Report Key | 5901448 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-22 |
| Date of Event | 2016-07-22 |
| Date Mfgr Received | 2016-07-26 |
| Date Added to Maude | 2016-08-24 |
| 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 | 0 |
| Brand Name | NEUROMEND |
| Generic Name | COLLAGEN NERVE WRAP |
| Product Code | JXI |
| Date Received | 2016-08-24 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2016-08-24 |