BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MICRO ACCESS KIT

    MDR report key: 1071082 · Received July 7, 2008

    Report

    Report Number
    MW5007541
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FEMALE PRESENTED TO PEDIATRIC EMERGENCY DEPT WITH COMPLAINTS OF ABDOMINAL PAIN AND FEVER. AN ABDOMINAL CT SCAN REVEALED A RUPTURED APPENDIX WITH A LARGE ABSCESS ADJACENT TO THE TIP OF THE APPENDIX. UNDERWENT CT GUIDED DRAINAGE OF ABSCESS WITH PLACEMENT OF DRAIN IN THE INTERVENTIONAL RADIOLOGY DEPT. A COMPLETION CT SCAN REVEALED A TINY LINEAR METALLIC FRAGMENT-APPROX 3-4MM, MOST LIKELY A RETAINED TIP OF THE GUIDEWIRE, IN THE ABDOMINAL WALL MUSCLE, ADJACENT TO THE DRAIN. FULL DISCLOSURE TO FAMILY, WITH NO PLANS TO RETRIEVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS MICRO ACCESS KIT ALL PURPOSE DRAIN GCY ANGIODYNAMICS H787065066120K

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other