BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G PROBE

    MDR report key: 1077639 · Received July 8, 2008

    Report

    Report Number
    1077639
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 7, 2008
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    DURING LASER PROBE TREATMENT, PATIENT SUSTAINED BURNS TO SURGICAL SITE (NASAL PORTION OF THE EYE). PATIENT'S CONJUNCTIVA WAS OPENED AND EXPLORED TO DETERMINE EXTENT OF DAMAGE, THEN SURGICALLY CLOSED WITH SUTURES.====================== MANUFACTURER RESPONSE FOR LASER PROBE, OCULIGHT SLX/11256-1======================MANUFACTURER HAS REQUESTED INFORMATION FROM PHYSICIAN TO COMPLETE A COMPLAINT FORM. NO OTHER INFORMATION REGARDING MANUFACTURER'S RESPONSE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G PROBE HANDPIECE, LASER GEX IRIDEX CORPORATION 11256-1 012604
    2 OCULIGHT SLX PHOTOCOAGULATOR GEX IRIDEX CORPORATION OCULIGHT SLX *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R