BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGICON DILATOM

    MDR report key: 23943749 · Received January 2, 2026

    Report

    Report Number
    MW5181571
    Event Type
    Injury
    Date Received
    January 2, 2026
    Report Date
    November 10, 2025
    Manufacturer
    RIGICON AS
    Product Code
    QGA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN EXPLANT OF THEIR RIGICON DEVICE (COMPETITOR DEVICE). THIS WAS DUE TO URETHRAL EROSION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765 RIGICON DILATOM PENILE IMPLANT SURGICAL ACCESSORIES QGA RIGICON AS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other