BEUDAMED
    FDA Adverse Event Summary report: N

    15X100MM OPITCAL ACCESS SYSTEM THREADED

    MDR report key: 2833810 · Received November 5, 2012

    Report

    Report Number
    2027111-2012-00337
    Date Received
    November 5, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 5, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803-56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP ADJUSTABLE BANDING AND REPAIR OF HERNIA - "TROCAR FELL APART AND BROKEN PIECE WENT INTO THE ABDOMEN. DR (B)(6) PULLED IT OUT WITH NO COMPLICATION TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15X100MM OPITCAL ACCESS SYSTEM THREADED NONE GCJ APPLIED MEDICAL C0R37 1175044

    Patients

    Seq Age Sex Outcome Treatment
    1