BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS MALLEABLE 11 MM

    MDR report key: 9241415 · Received October 25, 2019

    Report

    Report Number
    2125050-2019-00916
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    PMA / PMN Number
    K040959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORTS 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, INFECTION AFTER DEVICE IMPLANT. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032945 GENESIS MALLEABLE 11 MM PENILE PROSTHESIS FAE COLOPLAST A/S 5192602022 6713162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other