BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 19952466 · Received August 9, 2024

    Report

    Report Number
    2125050-2024-01214
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 30, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05701780273077
    PMA / PMN Number
    P000006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A MANUFACTURING INVESTIGATION VERIFIED THE PRODUCT WAS MADE TO SPECIFICATION. PER COLOPLAST SPECIFICATION, THE BLACK KRT WAS SHORTENED IN APPROXIMATELY IN (B)(6) 2023 THEN REVERTED BACK TO THE LONGER LENGTH IN APPROXIMATELY (B)(6) 2023 VIA CC-001030. THIS LOT WAS MANUFACTURED IN AUGUST 2023 WITH THE SHORTER BLACK KRT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF THE IMPLANT WAS TOO SHORT AND MADE PRIMING THE IMPLANT AND ATTACHING TO THE RESERVOIR DIFFICULT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF THE IMPLANT WAS TOO SHORT AND MADE PRIMING THE IMPLANT AND ATTACHING TO THE RESERVOIR DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205307 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S 9316298_ES29224022 05701780273077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown