BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 11807831 · Received May 11, 2021

    Report

    Report Number
    2125050-2021-00493
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    JCW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # 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.

    Description of Event or Problem · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED DUE TO A PUMP MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703633 TITAN INFLATABLE PENILE PROSTHESIS JCW COLOPLAST A/S QS89201400

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R