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

Model Number	00-52002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The wearable's questionnaire was reviewed for potential causes of the reported issue.The patient having contraindicating conditions and the patient having an incorrectly sized wearable have been ruled out.However, 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 stimulator is used to treat pain.The cause of the blisters 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 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 blisters after using the device.The patient met with implanting clinician, who stated the wound seems to be superficial.As of (b)(6) 2025, the blisters have not gone.However, medical intervention was not required.The commercial team member recommended not wearing the device directly on the skin.No further information is available at this time.

• 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: 23882829
• Report Number: 3010676138-2025-00296
• Device Sequence Number: 11929532
• Product Code: GZF
• UDI-Device Identifier: 00850051034192
• UDI-Public: (01)00850051034192(10)01376
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/23/2025

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 Model Number: 00-52002
• Device Lot Number: 01376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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
• Patient Age: 55 YR
• Patient Sex: Male