BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 10527876 · Received September 14, 2020

    Report

    Report Number
    2125050-2020-00839
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 29, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS IDENTIFIED IN THE RISK MANAGEMENT DOCUMENTATION AND REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD #(B)(4). ACCORDING TO THE AVAILABLE INFORMATION THE INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)96)2007, REMOVED AND REPLACED ON (B)(6)2020 DUE TO A BREAK IN THE TUBING FROM CYLINDER TO PUMP. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS OR COMMENT ON THE CONDITION OF THE PRODUCT. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT WILL BE RE-EVALUATED ACCORDING 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, NON-CONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 5690881. 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. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, BREAK IN TUBING FROM CYLINDER TO PUMP WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995887 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S QS89201000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR