BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS KIT 11 COATED

    MDR report key: 9313422 · Received November 12, 2019

    Report

    Report Number
    2125050-2019-01005
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 11, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    UDI-DI
    05708932324748
    PMA / PMN Number
    K040959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA REVIEW. NO TRENDS WERE NOTED. 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 OR 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, THE MALLEABLE ROD WAS REMOVED FROM THE LEFT SIDE. ON THE RIGHT SIDE, IT WAS REPORTED THAT THERE WAS NO ROD OR DEVICE IMPLANTED. THE MALLEABLE ROD WAS EXPLANTED AND REPLACED WITH AN INFLATABLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102466 GENESIS KIT 11 COATED PENILE PROSTHESIS FAE COLOPLAST A/S 5192601400 6147297 05708932324748

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other