BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 17409808 · Received July 27, 2023

    Report

    Report Number
    2125050-2023-00889
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Report Date
    November 1, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932950053
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NON-CONFORMING 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 · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE TITAN OTR WAS IMPLANTED ON (B)(6) 2014 AND REMAINS IMPLANTED. HOWEVER, IT WAS REPORTED THERE IS NO CIRCULATION IN THE DEVICE. APPARENTLY, THERE IS A LEAK OF LIQUID.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE IS NOT CYCLING AND HAS A FLUID LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662269 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 3601243_ESR9181022 05708932950053

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES| TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES| TITAN INFLATABLE PENILE PROSTHESIS FAMILY| TITAN INFLATABLE PENILE PROSTHESIS FAMILY