MAUDE Adverse Event Report: POLYGANICS INNOVATIONS BV NEUROCAP; NERVE CUFF

Model Number	NEUROCAP 1.5MM
Health Effect - Clinical Code	Seroma (2069)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Severe seroma formation at location dissolving neurocap.

• Brand Name: NEUROCAP
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): POLYGANICS INNOVATIONS BV; rozenburglaan 15a; groningen, groningen 9727D L; NL 9727DL
• MDR Report Key: 6559665
• Report Number: 3004504732-2017-00002
• Device Sequence Number: 19104687
• Product Code: JXI
• UDI-Device Identifier: 08717703990232
• UDI-Public: 08717703990232
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K152684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/08/2017
• Device Model Number: NEUROCAP 1.5MM
• Device Catalogue Number: NC01-015/03
• Device Lot Number: NCA2016060811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR