BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENT TUBE 1016010 5PK GOODE T 1.14X12MM

    MDR report key: 2895303 · Received January 3, 2013

    Report

    Report Number
    1045254-2013-00004
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETD
    PMA / PMN Number
    K802587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED (B)(4) 2013 INDICATED THAT THE EVENT TOOK PLACE (B)(6) 2012 AND THE PATIENT EXPERIENCED INFLAMMATION AND PURULENCE. THE DEVICE HAS BEEN EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE EXPLANT DATE IS UNKNOWN AND THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED. THE PATIENT HAS BEEN CURED. THE PATIENT WAS UNDER 10 YEARS OLD. THE PATIENT'S MEDICAL HISTORY INCLUDES TYMPANITIS. THE PHYSICIAN WAS DR. (B)(6). THIS WAS REPORTED TO NOT BE THE INITIAL USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). NO EXPLANT PROCEDURE WAS REPORTED, THEREFORE, IT IS ASSUMED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED AND THEREFORE, NO EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC THAT A VENT TUBE WAS IMPLANTED IN A PEDIATRIC PATIENT. AFTER THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INFECTION. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3661 VENT TUBE 1016010 5PK GOODE T 1.14X12MM TUBE, TYMPANOSTOMY ETD XOMED MFG JACKSONVILLE 1016010 0206005229

    Patients

    Seq Age Sex Outcome Treatment
    1 Other