BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 12293764 · Received August 9, 2021

    Report

    Report Number
    2125050-2021-01115
    Event Type
    Injury
    Date Received
    August 9, 2021
    Report Date
    November 17, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FWH
    UDI-DI
    05708932539111
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TITAN PUMP, ONE CYLINDER, AND A TOROSA SALINE-FILLED TESTICULAR IMPLANT WERE RECEIVED. (B)(6) 2021 10:30 AM (GMT-5:00) ADDED BY (B)(4): ACCORDING TO THE AVAILABLE INFORMATION THE TITAN TOUCH WAS IMPLANTED ON (B)(6) 2020 AND THE CYLINDER WAS REPLACED ON (B)(6) 2021 DUE TO A SIZING ISSUE. ADDITIONAL INFORMATION SAYS THAT THE OLD CYLINDER WAS REPLACED WITH A LARGER SIZE, NO ISSUE WITH THE DEVICE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE DEVICE. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. 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 · 1

    THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE CYLINDER WAS REPLACED WITH A LARGER-SIZED CYLINDER. THERE WAS NO ISSUE WITH THE DEVICE; THE REVISION WAS DUE TO A SIZING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190251 TITAN INFLATABLE PENILE PROSTHESIS FWH COLOPLAST A/S ES89162400 7493945 05708932539111

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention