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

Model Number	RESTOREX #117
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Pain (1994); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Tissue Irritation (4912)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer review determined no device malfunction or defect.The device was not returned for evaluation.The customer reported use at maximum tension settings over an extended period.Supporting medical records and images were requested but not provided.Based on available information and medical review, the reported injury could not be verified and no causal relationship to the device could be established based on available information.
Event or Problem Description
Customer reported that use of the restorex device resulted in a tear in the corpus spongiosum, worsening erectile function, urinary incontinence, and ongoing pain and inflammation.The customer stated the device was used according to instructions, including use at maximum tension settings over an extended period.Pathright requested supporting medical records and images to evaluate the allegations; however, no documentation was provided.Based on available information and internal review, the reported injuries were not verified, and no causal relationship to the device could be established.

• 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: 25191794
• Report Number: 3014159402-2026-00002
• Device Sequence Number: 13370525
• Product Code: LKY
• UDI-Device Identifier: 00860001453805
• UDI-Public: 0100860001453805
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: L-67
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male