BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURFX

    MDR report key: 7547202 · Received May 27, 2018

    Report

    Report Number
    3004135191-2018-00079
    Event Type
    Injury
    Date Received
    May 27, 2018
    Report Date
    May 27, 2018
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE DISTRIBUTOR TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTOS, AND SUN EXPOSURE, ONLY PATIENT PHOTOS WERE PROVIDED. LUMENIS HAS NOT BEEN CONTRACTED TO SERVICE THE SUBJECT DEVICE, THEREFORE NO EXAMINATION OF THE SUBJECT DEVICE OCCURRED. ALTHOUGH NO INFORMATION WAS PROVIDED BY THE DISTRIBUTOR ABOUT THE SERVICE HISTORY OF THE DEVICE, LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN SERVICE AT THE USER FACILITY. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE PROVIDED PATIENT PHOTO CONCLUDING: "THE CURRENT COMPLAINT IS PIH AT 1 MONTH AFTER THE PROCEDURE (INFORMATION OBTAINED BY PHONE CALL WITH THE DISTRIBUTOR) IN THE LOWER LIP REGION (LEFT SIDE ONLY). AFTER VITAMIN C TREATMENT, THE DISTRIBUTOR INFORMED THE PIH HAD ALMOST FULLY CLEARED. IT IS UNCLEAR WHY THE SKIN ONLY REACTED IN THIS LOCATION WHILE SAME SETTINGS DID NOT AFFECT REST OF FACE. THE INJURY AT TIME OF COMPLAINT IS MINOR. PATIENT ALMOST HEALED COMPLETELY WITHOUT ANY CHANGE OF PIGMENTATION LEFT. NON-SURGICAL TREATMENT WAS PROVIDED THROUGH USE OF A TOPICAL." THIS COMPLAINT HAS BEEN DETERMINED TO BE REPORTABLE PER MDR DECISION TREE, SINCE LUMENIS BELIEVES THAT HYPERPIGMENTATION IS PRESUMED PERMANENT IF STILL PRESENT AFTER 30 DAYS.

    Description of Event or Problem · 1

    A FOREIGN DISTRIBUTOR REPORTED THAT ONE (1) PATIENT SUSTAINED HYPERPIGMENTATION ON FACE AREA FOLLOWING TREATMENT WITH A LUMENIS RESURFX LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389563 RESURFX INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. RESURFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other