BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS KIT 9 COATED

    MDR report key: 9157951 · Received October 4, 2019

    Report

    Report Number
    2125050-2019-00842
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    August 15, 2019
    Report Date
    October 4, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    PMA / PMN Number
    K040959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MALLEABLE ROD WAS RECEIVED FOR EVALUATION. AS EXAMINATION OF THE DEVICE MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED DUE TO INFECTION, BELIEVED TO BE STAPHYLOCOCCUS AUREUS. THE PHYSICIAN NOTED TAKING APPROPRIATE PRECAUTIONS REGARDING INFECTION, BUT THAT PATIENT HYGIENE AND WOUND CARE WERE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952600 GENESIS KIT 9 COATED PENILE PROSTHESIS FAE COLOPLAST A/S 5192501000 5720183

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other