BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 14103541 · Received April 13, 2022

    Report

    Report Number
    2125050-2022-00381
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    October 26, 2021
    Report Date
    July 28, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932072595
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER (6050537) WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

    Additional Manufacturer Narrative · 0

    TITAN PUMP, CYLINDERS 1 AND 2, AND DETACHED CONNECTOR / INLET TUBING WERE RECEIVED FOR EVALUATION. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH NEITHER CYLINDER 1 NOR CYLINDER 2. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED CONNECTOR OR INLET TUBING. THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WANTED A DIFFERENT IMPLANT SIZE, AND THE DEVICE WAS IN POOR POSITION, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. 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 AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO PATIENT REQUESTING LONGER/LARGER CYLINDERS AS WELL AS AN UNSPECIFIED MALFUNCTION AND POOR PUMP POSITIONING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709759 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S EN88162400 6050537 05708932072595

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention