BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 23708685 · Received December 3, 2025

    Report

    Report Number
    2125050-2025-01874
    Event Type
    Injury
    Date Received
    December 3, 2025
    Report Date
    December 3, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED. CORRECTION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION IN MEDWATCH REPORT NUMBER MW5177819: "IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL INTERVENTION DURING WHICH A TITAN DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED".

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION IN MEDWATCH REPORT NUMBER MW5177819: " IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL INTERVENTION DURING WHICH A TITAN DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2846570 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention