BEUDAMED
    FDA Adverse Event Other Summary report: N

    8010047-2006-00124

    MDR report key: 805751 · Received December 21, 2006

    Report

    Report Number
    8010047-2006-00124
    Event Type
    Other
    Date Received
    December 21, 2006
    Product Code
    KOG
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THE COMPLAINT DATABASE HAS BEEN SEARCHED FOR A MATCH OF THIS COMPLAINT, BUT NO RESULT. THE REPORTER HAS BEEN CONTACTED FOR ADDITIONAL INFO, BUT NO FURTHER INFO HAS BEEN OBTAINED. NO CONCLUSION CAN BE DRAWN AT THIS TIME, HOWEVER, IF SIGNIFICANT INFO BECOMES AVAILABLE AT LATER DATE A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING FILED AS AN MDR IN AN EXCESS OF A CAUTION.

    Description of Event or Problem · 1

    THIS IS IN REFERENCE TO A REPORT THAT OLYMPUS RECEIVED ON DECEMBER 7, 2006. THE DESCRIPTION OF EVENT WAS "HYPOPHARYNGEAL TEAR RELATED TO UPPER ENDOSCOPY, SMALL CONTAINED LEAK PROMPTLY RECOGNIZED AND DIAGNOSED BY GASTROGRAFFIN SWALLOW STUDY. SUBJECT MADE NPO, IV FLUIDS AND ANTIBIOTICS WERE ADMINISTERED. SUBJECT WAS ADMITTED FOR SUPPORTIVE MANGEMENT AND RELEASED WITH NO COMPLICATIONS 3 DAYS LATER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOG

    Patients

    Seq Age Sex Outcome Treatment
    1