BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 16981481 · Received May 22, 2023

    Report

    Report Number
    2125050-2023-00608
    Event Type
    Injury
    Date Received
    May 22, 2023
    Report Date
    July 17, 2023
    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
    AL, 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. LOT NUMBER 5212074.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE TITAN WAS REVISED DUE TO BREAK IN TUBING OFF THE PUMP. 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.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THERE WAS A BREAK IN THE TUBING OFF THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462679 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QN89181400 05708932323901

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention