BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTOREX

    MDR report key: 25191794 · Received May 15, 2026

    Report

    Report Number
    3014159402-2026-00002
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    December 17, 2024
    Report Date
    May 15, 2026
    Manufacturer
    PATHRIGHT MEDICAL, INC.
    Product Code
    LKY
    UDI-DI
    00860001453805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583835 RESTOREX PENILE TRACTION DEVICE LKY PATHRIGHT MEDICAL, INC. RESTOREX #117 L-67 00860001453805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other