BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL 3

    MDR report key: 656094 · Received December 20, 2005

    Report

    Report Number
    6000032-2005-01979
    Event Type
    Other
    Date Received
    December 20, 2005
    Date of Event
    February 10, 2005
    Report Date
    November 14, 2005
    Manufacturer
    MEL REL, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED PT PRESENTED WITH SIGNS OF INFECTION JANUARY 2005. SYMPTOMS INCLUDED REDNESS, SWELLING AND PAIN. CULTURES WERE NOT OBTAINED. THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND TOTAL DEVICE SYSTEM EXPLANT. HCP REPORTED THE INFECTION RESOLVED. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 IPG GZB MEL REL, INC. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other