BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFRA ZERO ANG 20CM

    MDR report key: 6990275 · Received October 31, 2017

    Report

    Report Number
    2125050-2017-00542
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 29, 2017
    Report Date
    October 31, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    UDI-DI
    05708932487245
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MEDWATCH 5072577 - REPORT DEVICE FLUID LOSS - THERE APPEARS TO BE A BREAK AT THE RESERVOIR TUBING. THE PATIENT OPTED TO UNDERGO REPLACEMENT OF THE IPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769266 TITAN INFRA ZERO ANG 20CM INFLATABLE PENILE PROSTHESIS FHW COLOPLAST A/S ES88202400 5585205 05708932487245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other