BEUDAMED
    FDA Adverse Event Other Summary report: N

    12X100MM KII FIOS FIRST ENTRY THREADED 6/BOX

    MDR report key: 1914344 · Received November 16, 2010

    Report

    Report Number
    2027111-2010-00104
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    September 13, 2010
    Report Date
    November 16, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL AND NO LOT # HAS BEEN PROVIDED TO THE MFR FOR REVIEW. AN ENGINEERING ASSESSMENT OF THE INCIDENT IS CURRENTLY BEING CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    GASTRIC BAND, LAP - "PER MARCIA MURPHY, LAP BAND PROCEDURE PERFORMED BY DR. (B)(6), PROCEDURE WENT AS PLANNED. PT WAS FINE POST PROCEDURE AND WAS DISCHARGED AT A NORMAL TIME. PT CALLED AND COMPLAINED OF TROUBLE MOVING HIS BOWELS ON (B)(6). HE WAS BROUGHT BACK TO THE HOSPITAL AND A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED. A 3MM PERFORATION WAS IDENTIFIED IN THE LEFT COLON. A LAPAROSTOMY WAS DONE AND THE PERFORATION WAS REPAIRED." "DIAGNOSTIC LAPAROSCOPY FOLLOWED BY LAPAROSTOMY. PERFORATION WAS REPAIRED. PT DID WELL AND IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII FIOS FIRST ENTRY THREADED 6/BOX NONE GCJ APPLIED MEDICAL RESOURCES CFI83 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1