BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12X100MM THIRD SHIELDED TROCAR W/ UNIV SEAL

    MDR report key: 989403 · Received January 31, 2008

    Report

    Report Number
    2027111-2008-00001
    Event Type
    Injury
    Date Received
    January 31, 2008
    Date of Event
    September 14, 2006
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR. OUR ATTORNEY'S WERE CONTACTED BY OPPOSING COUNSEL INFORMING US OF A MAUDE REPORT THAT DESCRIBES A FAILURE OF ONE OF OUR TROCARS. THIS WAS THE FIRST TIME YOU BECAME AWARE OF THE EVENT AND YOU ASKED FDA FOR A COPY OF THE REPORT. THEY SENT IT ON NOV 26, 2007. THE REPORT STATES THAT A USER EXPERIENCED 7 INSTANCES OF NECROSIS IN THE NAVEL AND REFUSES TO USE THE PRODUCT ANYMORE. YOU ASKED REP OF THE FDA TO IDENTIFY THE USER BUT SHE WAS UNABLE TO DO SO. YOU REVIEWED OUR CER DATA BASE TO SEE IF SIMILAR COMPLAINTS WERE FILED ON THIS LOT (1023675) OF PRODUCT AND FOUND NONE. YOU ASKED CUSTOMER RELATIONS TO TRY AND IDENTIFY A HOSPITAL THAT MIGHT HAVE PURCHASED THIS PRODUCT ABOUT THE TIME THAT THE MAUDE REPORT WAS FILED. THEY COULDN'T COME UP WITH A SOLID MATCH. YOU THEN CREATED THE INITIAL CER PAPERWORK TO TRACK THIS ISSUE AS FURTHER INFORMATION SURFACES.

    Description of Event or Problem · 1

    "THIS TROCAR CAUSES UNDUE STRETCHING OF THE SKIN IN THE NAVEL RESULTING IN NECROSIS, PAIN AND SCARRING OF THE UMBILICAL. INCISION NOT SEEN IN MANY OTHER TROCARS I HAVE USED. THIS OCCURRED ALSO WITH SIX OTHER PTS I HAVE LAPAROSCOPED USING THIS TROCAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM THIRD SHIELDED TROCAR W/ UNIV SEAL UNK GCJ APPLIED MEDICAL RESOURCES C0659 1023675

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening