BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 12337439 · Received August 18, 2021

    Report

    Report Number
    2125050-2021-01160
    Event Type
    Injury
    Date Received
    August 18, 2021
    Report Date
    August 17, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932323901
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. LOT: 0935784.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, A TUBING LEAK WAS NOTED ON THE CYLINDER TO PUMP TUBING. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233938 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QN89181400 05708932323901

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention