BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1403392 · Received June 8, 2009

    Report

    Report Number
    2027111-2009-00052
    Event Type
    Other
    Date Received
    June 8, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 8, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AND EVAL OF INCIDENT DEVICE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "PHYSICIAN MAKING PUNCTURE FOR LAPAROSCOPIC CHOLECYSTECTOMY. LOOKING IN ABDOMEN AFTER ONE OF THE PUNCTURES A SMALL PIECE OF RUBBER WAS SEEN AND THEN REMOVED. ALL TROCARS AND PACKAGING WERE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GCJ APPLIED MEDICAL RESOURCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention