BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN OTR

    MDR report key: 12414302 · Received September 2, 2021

    Report

    Report Number
    2125050-2021-01251
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    August 7, 2020
    Report Date
    October 12, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/7/2022 AS FOLLOWS: THE PATIENT UNDERWENT A PROCEDURE TO IMPLANT A NEW DEVICE ON (B)(6) 2022.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 5925694. THE LOT NUMBER 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 DEVICE WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310645 TITAN OTR INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QNR9161022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention