BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 18691697 · Received February 12, 2024

    Report

    Report Number
    2125050-2024-00218
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 19, 2023
    Report Date
    June 4, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NON-CONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NON-CONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED.

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP, CYLINDERS 1 AND 2, RESERVOIR, AND DETACHED CONNECTOR/TUBING WERE RECEIVED FOR EVALUATION. ABRASION WAS NOTED ON BOTH EXHAUST TUBES AND THE INLET TUBE OF THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH EITHER CYLINDER 1 OR CYLINDER 2. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RESERVOIR. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE DETACHED CONNECTOR/TUBING. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD A PUMP MALFUNCTION, BUT BECAUSE NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RETURNED COMPONENTS, THE COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NONCONFORMING REPORTS OR CAPAS THAT WERE CONFIRMED TO BE ASSOCIATED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A PUMP MALFUNCTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306317 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 4215027_QSR9181022

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Required Intervention TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES| TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES| TITAN INFLATABLE PENILE PROSTHESIS FAMILY| TITAN INFLATABLE PENILE PROSTHESIS FAMILY