BEUDAMED
    FDA Adverse Event Other Summary report: N

    KII 5X100MM THR CANN/SEAL

    MDR report key: 1316653 · Received February 17, 2009

    Report

    Report Number
    2027111-2009-00012
    Event Type
    Other
    Date Received
    February 17, 2009
    Date of Event
    January 22, 2009
    Report Date
    February 17, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS CURRENTLY BEING EVALUATED. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "I HAVE A TMA WHO WAS IN THIS CASE AND, THE MD ACTUALLY SHOWED TRIPP THE "PIECE" OF THE SEAL THAT HE SAID HE GOT OUT OF HIS PATIENT. TRIPP WASN'T ACTUALLY ABLE TO RETRIEVE THE PIECE, BUT THE STAFF SAID THEY SENT IN A CER LAST WEEK FOR THE SAME KIND OF INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII 5X100MM THR CANN/SEAL NONE GCJ APPLIED MEDICAL RESOURCES CORP. C0Q10 1076185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention