BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BETCHTOLD

    MDR report key: 409549 · Received August 2, 2002

    Report

    Report Number
    409549
    Event Type
    Injury
    Date Received
    August 2, 2002
    Date of Event
    April 24, 2002
    Report Date
    June 29, 2002
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATIVE PROCEDURE THE SURGEON ALIGNING THE OVERHEAD SURGICAL LIGHT BUMPED THE BASE OF THE CENTRAL COLUMN WITH THE LIGHT HOUSING. PAINT FLECKS FELL OFF THE CENTRAL COLUMN ONTO THE STERILE FIELD. IT IS POSSIBLE THAT FLECKS WERE INTRODUCED INTO THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BETCHTOLD LIGHT, SURGICAL, DUAL HEAD FSY BERCHTOLD CORP. C570570D *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention