BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTOREX

    MDR report key: 25191793 · Received May 15, 2026

    Report

    Report Number
    3014159402-2026-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    October 2, 2023
    Report Date
    May 15, 2026
    Manufacturer
    PATHRIGHT MEDICAL, INC.
    Product Code
    LKY
    UDI-DI
    00860001453805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243821 RESTOREX PENILE TRACTION DEVICE LKY PATHRIGHT MEDICAL, INC. RESTOREX #117 26 00860001453805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male