MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study,user facility report with the FDA on 2017-05-11 for NEUROCAP NEUROCAP 1.5MM NC01-015/03 manufactured by Polyganics Innovations Bv.
[74902876]
Patient is participating in (b)(6) clinical study stop neuroma (clinicaltrials. Gov identifier: (b)(6)). Below an overview of sequence of events: on (b)(6) 2016 surgery. No complications or remarks. Neurocap 1. 5 mm implanted. Wk of (b)(6) 2016 surgeon indicates to polyganics representative that patient hit operation site on corner of night table; ae was most probably discovered when removing stitches at 10-day follow up. Ae was indicated by surgeon as non-device related, just an unfortunate event. On (b)(6) 2017 ae reported in ecrf regarding accident indicated "bumped operated hand on corner night table". Causality is marked "other". Date of onset is marked as (b)(6) 2017. The ae is graded mild, not related to the study procedure and not related to the study device. The action taken in resolving the ae was closing the wound with adhesive strips. On (b)(6) 2017 6-week follow up visit. The ae at the operational site is noted to be resolved without sequelae. Around this time the ae was also discussed informally with the surgeon by a polyganics representative. The ae was again noted to be an unfortunate event rather than device related. On (b)(6) 2017 3-month follow up. Seroma formation at the operational site, likely originating from the earlier ae but the latter was not confirmed in writing. On (b)(6) 2017 sae noted. Event onset reported to be (b)(6) 2017. Causality noted as "disease under study". Ongoing sae, which resulted in re-intervention in the week of (b)(6) (estimate, to be confirmed with surgeon). (remainder of) neurocap was removed, further actions in surgery unknown at time of this report. Surgeon indicated by (informal) email at inquiry after the patient's well being at (b)(6) 2017 that the patient was healing alright after immobilisation. Surgeon's response per email: despite antibiotics, persistent swelling causing reintervention. Removed material was tested by the lab: negative growth, so no bacterial infection. The patient is now recovering. Product not returned as it is degraded.
Patient Sequence No: 1, Text Type: N, H10
[74902877]
Severe seroma formation at location dissolving neurocap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004504732-2017-00002 |
| MDR Report Key | 6559665 |
| Report Source | STUDY,USER FACILITY |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-05-11 |
| 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, GRONINGEN 9727DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 9727DL |
| Manufacturer Phone | 05886598 |
| Manufacturer G1 | POLYGANICS INNOVATIONS BV |
| Manufacturer Street | ROZENBURGLAAN 15A |
| Manufacturer City | GRONINGEN, 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 | NEUROCAP |
| Generic Name | NERVE CUFF |
| Product Code | JXI |
| Date Received | 2017-05-11 |
| Model Number | NEUROCAP 1.5MM |
| Catalog Number | NC01-015/03 |
| Lot Number | NCA2016060811 |
| Device Expiration Date | 2017-12-08 |
| 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, GRONINGEN 9727DL NL 9727DL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-11 |