MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-22 for NEUROLAC manufactured by Polyganics Innovations Bv.
| Report Number | 3004504732-2018-00003 |
| MDR Report Key | 8920484 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-22 |
| Date of Report | 2019-08-22 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2019-08-22 |
| 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, 9727DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 9727 DL |
| 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 | 2019-08-22 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-08-22 |