BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLOPLAST INTIBIA

    MDR report key: 23605630 · Received November 20, 2025

    Report

    Report Number
    MW5179158
    Event Type
    Injury
    Date Received
    November 20, 2025
    Report Date
    November 18, 2025
    Manufacturer
    COLOPLAST
    Product Code
    QPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED SHE "JUST FINISHED A CLINICAL TRIAL WITH THE COLOPLAST INTIBIA DEVICE AND HAD IT REMOVED" BECAUSE IT DIDN'T WORK VERY WELL. 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
    2489750 COLOPLAST INTIBIA STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE QPT COLOPLAST

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown