MAUDE Adverse Event Report: PATHRIGHT MEDICAL, INC. RESTOREX; PENILE TRACTION DEVICE

Model Number	RESTOREX #117
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypoesthesia (2352); Erectile Dysfunction (4511)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer received complaint from consumer reporting erectile dysfunction and decreased penile sensitivity following use of the restorex device.Consumer reported evaluation by urologist; no documentation confirming device-related injury was provided.Device was not returned for evaluation.No malfunction or device defect was identified.Based on available information, a causal relationship between the device and the reported symptoms could not be established.This report is being submitted in an abundance of caution.
Event or Problem Description
Patient reported using the device approximately 5 hours per day, exceeding the instructions for use which state not to use the device for more than 1 hour per day or more than 30 minutes at a time and to separate sessions by at least 30 minutes.The patient also reported tightening the clamp beyond normal use and applying maximum tension, sometimes manually increasing force.The patient reported decreased penile sensitivity and weaker erections.On (b)(6) 2023 the patient was evaluated by a urologist and underwent a penile ultrasound on (b)(6) 2023.The patient reported that the ultrasound showed numerical findings suggestive of a possible venous leak.No surgical intervention or hospitalization was reported.The patient was advised to discontinue use.Follow up communication months later indicated that the patient reported his condition had returned to normal.No device malfunction was reported.

• Brand Name: RESTOREX
• Common Device Name: PENILE TRACTION DEVICE
• Manufacturer (Section D): PATHRIGHT MEDICAL, INC.; 1443 w 800 n ste 303; orem UT 84057 2883
• Manufacturer (Section G): PATHRIGHT MEDICAL, INC; 1443 w 800 n ste 303; orem UT 84057 2883
• Manufacturer Contact: preston lines ; 1443 w 800 n ste 303; orem, UT 84057-2883 ; 8772285147
• MDR Report Key: 25191793
• Report Number: 3014159402-2026-00001
• Device Sequence Number: 13370524
• Product Code: LKY
• UDI-Device Identifier: 00860001453805
• UDI-Public: 0100860001453805
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: RESTOREX #117
• Device Lot Number: 26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2023
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male