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

Lot Number	01282
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The wearables questionnaire was reviewed for potential causes of the reported issue.Based on this review, the wearable was placed directly on the skin which is non-complaint 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 cause of the reported issue to due to non-compliance to the ifu as the wearable was placed directly on the skin (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in wearable issues.Wearable issue rates remain acceptably low; thus, a capa is not required at this time.Wearable issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported their wearable was causing an allergic reaction to their skin which resulted in skin dermatitis and small blister like pustules around the area of the wearable.An antibiotic ointment was prescribed and the area was covered with gauze.The patient was instructed to refrain from wearing the device for a few days and will wear a barrier between the wearable and their skin.The patient noticed the formation of new blisters on (b)(6) 2025 and was seen by their dermatologist on (b)(6) 2025.The patient's blisters have started to heal, cultures of the area were obtained, and antibiotics were prescribed.The results of the cultures are not available at this time and further information is not available.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: WEARABLE ACCESSORY
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central blvd s; pompano beach, FL 33064
• MDR Report Key: 22331697
• Report Number: 3010676138-2025-00130
• Device Sequence Number: 20905075
• Product Code: GZF
• UDI-Device Identifier: 00850051034208
• UDI-Public: (01)00850051034208(10)01282
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• 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): 06/25/2025

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 Lot Number: 01282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male