BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 19435326 · Received May 31, 2024

    Report

    Report Number
    2125050-2024-00827
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    April 5, 2024
    Report Date
    August 28, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932539203
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TITAN TOUCH, TWO CYLINDERS AND RESERVOIR WERE RECEIVED FOR EVALUATION. AS EXAMINATION OF THE COMPONENTS MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF MIGRATION, 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH WAS REMOVED AND REPLACED WITH A GENESIS DUE TO THE CYLINDER BEING OUT OF THE CORPORA.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH WAS REMOVED AND REPLACED WITH A GENESIS DUE TO THE CYLINDER BEING OUT OF THE CORPORA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331259 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 9264808_ES29222400 05708932539203

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention