BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN

    MDR report key: 769192 · Received October 12, 2006

    Report

    Report Number
    2125050-2006-00297
    Event Type
    Injury
    Date Received
    October 12, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 12, 2006
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS PENDING, THE DECONTAMINATION OF THE COMPONENT(S). AN EVALUATION WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION, THERE WAS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN INFLATABLE PENILE PROSTHESIS FHW COLOPLAST MANUFACTURING US, LLC 90-9918SC 23193

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R