MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for NEUROMEND CNW12025 manufactured by Collagen Matrix, Inc..
[131894681]
Review of the device history records and additional testing of the reserve samples confirms that the product meets acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10
[131894682]
Following initial procedure the patient complained of redness and swelling. Subsequently, the patient underwent revision surgery to perform drainage, debridement and partial removal of the device. No additional adverse events associated with this incident have been reported to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2018-00013 |
| MDR Report Key | 8209441 |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-28 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2016-11-21 |
| Date Added to Maude | 2019-01-02 |
| 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 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 | 2019-01-02 |
| Model Number | CNW12025 |
| Lot Number | 1611211032 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2019-01-02 |