MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-07 for NEUROLAC NEUROLAC 6.0 MM NG01-060/03 manufactured by Polyganics Innovations Bv.
[94130005]
Initial surgery on (b)(6) 2017: neurolysis on the right median nerve. Early (b)(6) 2017 the patient returned to the surgeon with complaints of redness and swelling. Patient was requested to cool the site and was subscribed antibiotics. On (b)(6) the patient returned to the surgeon who observed too little improvement upon which she decided to do a surgery on (b)(6) by opening the wound and rinse the site.
Patient Sequence No: 1, Text Type: N, H10
[94130006]
Approximately 3,5 months after surgery the patient developed a swelling at the site of implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004504732-2017-00003 |
| MDR Report Key | 7094729 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-07 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-10-15 |
| Date Added to Maude | 2017-12-07 |
| 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 BETTY IJMKER |
| Manufacturer Street | ROZENBURGLAAN 15A |
| Manufacturer City | GRONINGEN, 9727DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 9727DL |
| Manufacturer G1 | POLYGANICS INNOVATIONS BV |
| Manufacturer Street | ROZENBURGLAAN 15A |
| Manufacturer City | GRONINGEN, 9727DL |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9727DL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROLAC |
| Generic Name | NERVE CUFF |
| Product Code | JXI |
| Date Received | 2017-12-07 |
| Model Number | NEUROLAC 6.0 MM |
| Catalog Number | NG01-060/03 |
| Lot Number | NGA2015101511 |
| Device Expiration Date | 2019-04-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POLYGANICS INNOVATIONS BV |
| Manufacturer Address | ROZENBURGLAAN 15A GRONINGEN, 9727DL NL 9727DL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-07 |