BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS KIT 9.5 COATED

    MDR report key: 9204923 · Received October 17, 2019

    Report

    Report Number
    2125050-2019-00881
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 11, 2019
    Report Date
    December 10, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    PMA / PMN Number
    K040959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP WAS CREATED TO DOCUMENT THE CORRECTED DEVICE INFORMATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS OR COMMENT ON THE CONDITION OF THE PRODUCT. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT WILL BE RE-EVALUATED ACCORDING TO PROCEDURES. 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, NONCONFORMANCE'S AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP WAS CREATED TO DOCUMENT THE METHOD CODES.

    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. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION. A MALLEABLE WAS EXPLANTED, REPLACING WITH IPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998405 GENESIS KIT 9.5 COATED PENILE PROSTHESIS FAE COLOPLAST A/S 5192501400 5169669

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other