BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 9504446 · Received December 20, 2019

    Report

    Report Number
    2125050-2019-01168
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    October 31, 2019
    Report Date
    January 28, 2020
    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 · 0

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. AS EXAMINATION OF THE DEVICE MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PLACEHOLDER QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. AS NO LOT # WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATED THE MALLEABLE DEVICE WAS IMPLANTED TO HOLD SPACE IN THE CORPORA

    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 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 DEVICE WAS REMOVED FROM RIGHT SIDE, AND AN INFLATABLE DEVICE WAS INSERTED ON BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298046 GENESIS PENILE PROSTHESIS FAE COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other