BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER

    MDR report key: 8280319 · Received January 27, 2019

    Report

    Report Number
    3004135191-2019-00011
    Event Type
    Injury
    Date Received
    January 27, 2019
    Report Date
    January 27, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K170179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT DID NOT PROVIDE THE NAME OF THE FACILITY WHERE THE REPORTED EVENT OCCURRED, NOR WAS THE COMPLAINT ABLE TO PROVIDE EXACT DEVICE INFORMATION. THEREFORE, THE COMPLAINT DEVICE COULD NEITHER BE CONFIRMED NOR COULD AN ANALYSIS OF THE COMPLAINT DEVICE BE COMPLETED. PHOTOS OF THE INJURY HAD BEEN PROVIDED. A LUMENIS CLINICAL DIRECTOR EVALUATED THE PHOTOS AND DETERMINED THAT (FROM THE PHOTOS) "A BURN WITH BLISTERS IS TYPICAL OF 2ND-DEGREE BURNS. LOWER ANKLES HEAL VERY SLOWLY COMPARED TO OTHER AREAS (EVEN BRUISES LAST LONGER ON LEGS GENERALLY AS COMPARED TO OTHER ANATOMICAL AREAS). "INVOLVING BOTH THE EPIDERMIS AND THE PAPILLARY DERMIS, SUPERFICIAL SECOND-DEGREE BURNS WILL USUALLY HEAL IN ONE TO TWO WEEKS WITH NO SIGNIFICANT SCARRING." (SOURCE: HTTPS://WWW.CLINICALADVISOR.COM/FEATURES/WHEN-TO-TREAT-OR-REFER-A-BURN-INJURED-PATIENT/ARTICLE/206807/). THE CLINICAL DIRECTOR FURTHER NOTED THAT "BASED ON THE PHOTOS AND DUE TO MEDICAL INTERVENTION (IV ANTIBIOTICS FOR 5 DAYS), THIS HAS BEEN CLASSIFIED AS A "SERIOUS INJURY, WITH LITTLE LIKELIHOOD OF PERMANENT IMPAIRMENT (MINOR SCARRING IS POSSIBLE AND LIKELIHOOD LIMITED AS BLISTERS HAVE LIMITED SIZE; ELSE TRANSIENT CHANGE OF PIGMENTATION EXCEEDING 30 DAYS)." ALTHOUGH THE COMPLAINT DEVICE COULD NOT BE CONFIRMED, IN AN ABUNDANCE OF CAUTION LUMENIS IS REPORTING THIS EVENT. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4), LUMENIS DISTRIBUTER IN (B)(4) WERE UPDATED AFTER 6 DAYS AND DECIDED NOT TO REPORT THE ADVERSE EVENT TO (B)(6)DUE TO THE LACK OF INFORMATION ON FACILITY, DEVICE SERIAL NUMBER AND OTHER ADDITIONAL INFORMATION IN WHICH THEY FIND IMPORTANT TO SUBMIT A (B)(6) MDR. THE COMPLAINANT STATED SHE IS IN A LEGAL DISPUTE AND WAS ADVISED BY HER LAWYER NOT TO SHARE ANY MORE INFORMATION. THEREFORE, LUMENIS IS CLOSING THIS COMPLAINT DUE TO LACK OF SUFFICIENT INFORMATION PROVIDED TO INVESTIGATE FURTHER.

    Description of Event or Problem · 1

    FOLLOWING A HAIR REMOVAL TREATMENT DONE WITH A LUMENIS LIGHTSHEER AT A FOREIGN FACILITY, A PATIENT REPORTED TO LUMENIS SUFFERING 2ND DEGREE BURNS. THE PATIENT REPORTED HAVING TO GO TO THE HOSPITAL FOR BURN DRESSINGS AS HER LOWER ANKLES WERE ALL BLISTERED AND SWOLLEN. THE PATIENT REPORTED HAVING FURTHER DEVELOPED AN INFECTION AND NEEDED IV ANTIBIOTICS FOR 5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73194 LIGHTSHEER INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD. LIGHTSHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other