MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-01 for NEUROLAC NEUROLAC 8.0 MM NG01-080/03 manufactured by Polyganics Innovations Bv.
[109745799]
No lot number was available. A foreign body reaction occurred but it cannot be determined on the information available if this was caused by neurolac. Foreign body reactions may occur, and they are addressed in the product risk management file and documented in our instructions for use. If new information will become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[109745800]
Patient had a glas wound in the mid nerve (nervus medianus), formation of neuroma, no feeling in fingers except distal p dig 3 and no function. The surgeon removed the neuroma; the gap created in the nerve was bridged by using neurolac (implantation (b)(6) 2017). Post op info: nerve recovered well, finger function and sense much better. On (b)(6) 2017 a swelling (bump) was seen. Antibiotics prescribed and after that spontaneous relief. On (b)(6) 2018 explantation because the patient had pain, a bump and stiff fingers. After explantation the surgery site is now calm; patient is satisfied with function/result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004504732-2018-00002 |
| MDR Report Key | 7559946 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-06-01 |
| 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 | MRS BETTY IJMKER |
| Manufacturer Street | ROZENBURGLAAN 15A |
| Manufacturer City | GRONINGEN, 9727NL |
| Manufacturer Country | NL |
| Manufacturer Postal | 9727 NL |
| Manufacturer G1 | POLYGANICS INNOVATIONS BV |
| Manufacturer Street | ROZENBURGLAAN 15A |
| Manufacturer City | GRONINGEN, 9727DL |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9727 DL |
| 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 | 2018-06-01 |
| Model Number | NEUROLAC 8.0 MM |
| Catalog Number | NG01-080/03 |
| 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 9727 DL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-01 |