BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 16992155 · Received May 24, 2023

    Report

    Report Number
    2125050-2023-00622
    Event Type
    Injury
    Date Received
    May 24, 2023
    Report Date
    May 24, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487320
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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 0922573.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO FLUID LOSS. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371457 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES89162400 05708932487320

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Required Intervention