BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PETITE WOUND DRAINAGE SYSTEM

    MDR report key: 22057 · Received May 8, 1995

    Report

    Report Number
    22057
    Event Type
    Injury
    Date Received
    May 8, 1995
    Date of Event
    April 24, 1995
    Report Date
    May 8, 1995
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE COURSE OF REMOVING DRAIN, A PORTION OF THE DRAIN BROKE OFF AND REMAINED UNDER THE SKIN. REMOVED WITH LOCAL ANESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PETITE WOUND DRAINAGE SYSTEM Implant WOUND DRAIN GCY AXIOM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention