BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 19332294 · Received May 16, 2024

    Report

    Report Number
    2125050-2024-00767
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 24, 2024
    Report Date
    July 31, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TITAN TOUCH PUMP AND TWO CYLINDERS WERE RECEIVED FOR EVALUATION WERE RECEIVED FOR EVALUATION. AS EXAMINATION OF THE COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514087 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 8091524_ES29202400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention