BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERCHTOLD

    MDR report key: 209053 · Received February 9, 1999

    Report

    Report Number
    1220685-1999-00002
    Event Type
    Injury
    Date Received
    February 9, 1999
    Date of Event
    January 14, 1999
    Report Date
    January 14, 1999
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CALL WAS REC'D BY THE MFR FROM THE USER FACILITY THAT DURING SURGERY THE GLASS IN THE LIGHT HANDLE OF AN OVERHEAD SURGICAL LIGHT HAD BROKEN DURING THE MOVEMENT OF THE LIGHT. THE PERSON REPORTING THE INCIDENT INDICATED THAT FRAGMENTS OF GLASS HAD APPARENTLY FALLEN INTO THE EYES OF THREE STAFF MEMBERS AND INTO THE OPEN KNEE INCISION OF THE PT. DURING THE FOLLOW-UP INVESTIGATION BY THE MFR, THE BROKEN HANDLE WAS REPLACED AND THE DAMAGED HANDLE WAS RETURNED TO THE MFR FOR INSPECTION. THE HANDLE HAS BEEN SENT TO THE MFR'S PARENT CO IN GERMANY FOR INVESTIGATION OF CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERCHTOLD SURGICAL LIGHT FQP BERCHTOLD CORP. C950AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention