BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE XL 3000/5000

    MDR report key: 834776 · Received April 2, 2007

    Report

    Report Number
    2914019-2007-00009
    Event Type
    Other
    Date Received
    April 2, 2007
    Date of Event
    January 24, 2007
    Report Date
    April 2, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS REGULATORY HAS NO PREVIOUS REPORTS OF RECORD OF A DIAGNOSIS OF KERATO CONJUNCTIVITIS IN POST-CO2 RESURFACING PATIENTS. PHYSICIAN STATED THAT SHE PERFORMS A HIGH VOLUME OF CO2 RESURFACING PROCEDURES AND HAS NEVER SEEN THIS TYPE OF PROBLEM FOLLOWING CO2 RESURFACING. PHYSICIAN ALSO STATED THAT, SHE CONSULTED WITH A CO2 LASER CLINICAL EXPERT WHOSE OFFICE HAS NOT HEARD OF A REPORT OF THIS TYPE. AS THIS APPEARS TO BE A UNIQUE REPORT, LUMENIS REGULATORY DID NOT RECOMMEND DEVICE EVALUATION.

    Description of Event or Problem · 1

    PER THE PHYSICIAN, A PATIENT REPORTED PAIN AND TEARING BILATERALLY, RIGHT EYE GREATER THAN LEFT EYE, AND HAD A PUSSY EXUDATE, 6 DAYS AFTER UNDERGOING CO2 LASER RESURFACING TO THE ENTIRE FACE AND EYELIDS. PER INITIAL REPORT FROM THE PHYSICIAN, THE PATIENT APPEARED TO HAVE AN EYE INFECTION, WHICH THE PHYSICIAN TREATED WITH OPHTHALMIC BACITRACIN ANTIBIOTIC OINTMENT (OVER-THE-COUNTER), AND THE PATIENT MAY ALSO HAVE SCRATCHED HER EYES. THE PHYSICIAN STATED THAT IN HER OPINION, THE PATIENT'S EYE CONDITION IS NOT RELATED TO THE LASER OR THE LASER TREATMENT. THE PT WAS FITTED WITH THE METAL EYE SHIELDS PRIOR TO THE LASER TREATMENT. THE PATIENT WAS EVALUATED ON THE 6TH DAY POST-RESURFACING BY AN OPHTHALMOLOGIST WHO DIAGNOSED KERATO CONJUNCTIVITIS. BASED ON THE INITIAL DETAILS, THE COMPLAINT WAS DETERMINED NOT TO BE MDR REPORTABLE. PER FOLLOW-UP DETAILS RECEIVED FROM THE PHYSICIAN IN 2007, THE PHYSICIAN HAD GIVEN THE PATIENT BACTROBAN (PRESCRIPTION), NO BACITRACIN. THE PHYSICIAN ALSO PROVIDED NEW DETAILS THAT THE CONSULTING OPHTHALMOLOGIST HAD PRESCRIBED TOBRADEX. BASED ON THIS NEW INFORMATION, THE INCIDENT WAS RECLASSIFIED AS MDR REPORTABLE. PER THE PHYSICIAN, AS OF THE SAME DAY, THE PATIENT REPORTED THAT SHE IS NOW FINE OR JUST ABOUT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE XL 3000/5000 CARBON DIOXIDE SURGICAL LASER GEX LUMENIS LTD. XL5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention NONE REPORTED