BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINETRA

    MDR report key: 685785 · Received March 10, 2006

    Report

    Report Number
    6000032-2006-00423
    Event Type
    Other
    Date Received
    March 10, 2006
    Report Date
    March 6, 2006
    Manufacturer
    MEL REL, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS IPG SYSTEM REMOVAL DUE TO REPEATED INFECTIONS. SIGNS OF INFECTION INCLUDED ERYTHEMA, REDNESS, SKIN BREAKDOWN, POOR WOUND HEALING AND SWELLING. CULTURES ARE PENDING AT THE TIME OF THIS REPORT. THE PT WAS TREATED WITH ANTIBIOTICS, REPOSITIONING, WASHOUT, PLASTICS CLOSURE AND, FINALLY COMPLETE IPG SYSTEM REMOVAL. THE DEVICE WAS EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA IPG GZB MEL REL, INC. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other