BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS MALLEABLE

    MDR report key: 13214968 · Received January 10, 2022

    Report

    Report Number
    2125050-2022-00028
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 13, 2021
    Report Date
    March 24, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAE
    PMA / PMN Number
    K040959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER: 7041173. B1 CORRECTED FROM "ADVERSE EVENT AND PRODUCT PROBLEM" TO "ADVERSE EVENT".

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179927 GENESIS MALLEABLE PENILE PROSTHESIS FAE COLOPLAST A/S 5192501022

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention