BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE CPT SYSTEM

    MDR report key: 9623345 · Received January 23, 2020

    Report

    Report Number
    3011423170-2020-00012
    Event Type
    Injury
    Date Received
    January 23, 2020
    Date of Event
    December 5, 2019
    Report Date
    December 26, 2019
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K132431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    BASED ON THE EVALUATION OF THE DATA CARD LOGS AND HANDPIECE, THE SYSTEM AND HANDPIECE PERFORMED AS EXPECTED. THE PHYSICIAN ATTRIBUTED THE INJURY TO THE EYE SHIELDS. FOR THERMAGE EYE TREATMENTS, THE USER MUST FOLLOW STANDARD PRECAUTIONS FOR THE PLACEMENT AND USE OF THE EYE SHIELDS TO AVOID RISK OF CORNEAL ABRASIONS OR OCULAR DAMAGE. EYE SHIELDS ARE NOT PROVIDED BY SOLTA. BASED ON THE AVAILABLE INFORMATION, THIS EVENT WAS CAUSED BY THE OCULAR SHIELDS USED DURING TREATMENT.

    Description of Event or Problem · 0

    CLARIFYING INFORMATION HAS BEEN RECEIVED. CORNEAL DAMAGE OCCURRED IN BOTH EYES. A SCRATCHED SPOT WAS NOTED NEXT TO THE IRIS OF THE RIGHT EYE WHILE SCRATCHES WERE OBSERVED OVER THE PUPIL AREA OF THE LEFT EYE.

    Additional Manufacturer Narrative · 1

    THE REPORTER CONFIRMED THAT PRIOR TO THE TREATMENT, THE TIP WAS INSPECTED AS WELL AS SEVERAL TIMES THROUGHOUT THE PROCEDURE AND NOTHING WAS NOTED ON THE SURFACE. THE TIP IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY LOG IS CURRENTLY IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT AFTER A LASER TREATMENT TO THE EYELIDS, A LITTLE ROUND SPOT ON THE CORNEA APPEARED AND THE PATIENT EXPERIENCED POOR VISION. THE PHYSICIAN STATED THE PATIENT'S CORNEA WAS INJURED. DURING TREATMENT, AN EYE SHIELD WAS USED WITH VIDISIC GEL EYE SHIELD LUBRICANT. IN THE OPINION OF THE PHYSICIAN, THE CORNEAL INJURY MAY HAVE BEEN DUE TO RUBBING OF THE EYES SHIELDS ON THE EYE, DURING TREATMENT. SOLTA MEDICAL, INC. DOES NOT MANUFACTURE THE EYE SHIELDS. THE DOCTOR PRESCRIBED AN UNKNOWN OPHTHALMIC TREATMENT FOR THE EVENT. THE PATIENT WAS ADMINISTERED AN UNKNOWN SUPERFICIAL ANESTHETIC AND AN UNKNOWN IV MEDICATION PRIOR TO THE TREATMENT. AVAILABLE IMAGES WERE REVIEWED AND A RED SPOT WAS VISIBLE BY THE SIDE OF THE CORNEA OF THE RIGHT EYE. ACCORDING TO THE OPHTHALMOLOGIST, THE PATIENT'S EYESIGHT SEEMS TO BE RECOVERING AND THE PATIENT MAY FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86018 THERMAGE CPT SYSTEM ELECTROSURGICAL,CUTTING & COAGULATION & ACC. GEI SOLTA MEDICAL, INC. TTNS0.25NB1-450

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other