MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR; WEARABLE ACCESSORY

Model Number	00-52004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.The wearable was placed directly on the skin which is non-compliant to the ifu.Per curonix pns wearable quick reference card, 06-02923, "product is to be worn over a thin layer of clothing at all times.Do not place directly on skin." the wearable associated with the complaint was returned for investigation.The investigation was unable to replicate the alleged issue, and no non-conformances were found.Additionally, per 02-52004 viviana arm calf wearable phrf, the product met specification as it measured 48.6cm long and the specification is 48 ±.6cm.The stimulator is used to treat pain.The cause of the reported issue is due to non-compliance to the ifu as the patient wore the wearable directly on the skin (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported irritation and bubbling on their skin underneath where the wearable is worn.Topical ointment was used and as of (b)(6) 2026, the skin is healing.The commercial team member instructed the patient to wear the wearable over a sock or pants and to not place it directly on the skin.The patient has a follow up appointment on (b)(6) 2026.No further information is available.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: WEARABLE ACCESSORY
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 24618691
• Report Number: 3010676138-2026-00044
• Device Sequence Number: 18538291
• Product Code: GZF
• UDI-Device Identifier: 00850051034208
• UDI-Public: (01)00850051034208(10)01157
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: Lay User/Patient
• Device Model Number: 00-52004
• Device Lot Number: 01157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male