BEUDAMED
    FDA Adverse Event Summary report: N

    KII FIOS FIRST ENTRY Z-THREAD

    MDR report key: 2770241 · Received August 24, 2012

    Report

    Report Number
    2770241
    Date Received
    August 24, 2012
    Date of Event
    March 23, 2012
    Report Date
    June 6, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    DRC
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN CHANGES AND PUCKERING FOUND AT THE SURGICAL SITE IN FOLLOW UP APPOINTMENTS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII FIOS FIRST ENTRY Z-THREAD TROCAR DRC APPLIED MEDICAL 12X100MM 1163931

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES