BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 19238069 · Received May 3, 2024

    Report

    Report Number
    2125050-2024-00704
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 30, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 SPECIFICATIONS PRIOR TO RELEASE. NO TRENDS WERE NOTED FOR COMPLAINTS AND THERE WERE NO NON-CONFORMING REPORTS OR CAPA'S THAT WERE CONFIRMED IN VEEVA TO BE ASSOCIATED.

    Additional Manufacturer Narrative · 0

    TITAN OTR PUMP, CYLINDERS 1 AND 2, AND RESERVOIR 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 CYLINDER 1 OR CYLINDER 2. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE RESERVOIR. THE INFORMATION RECEIVED INDICATED THE DEVICE HAD A POSSIBLE LEAK; HOWEVER, NO ABNORMALITIES WERE SEEN BY THE PHYSICIAN UPON EXPLANTATION. BASED ON THE INVESTIGATION AND TESTING PERFORMED, 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. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A POSSIBLE LEAK.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A POSSIBLE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022006 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 3893900_ESR8202400

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention