BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICOSURE

    MDR report key: 19148867 · Received April 19, 2024

    Report

    Report Number
    1222993-2024-00018
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 19, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K210226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CYNOSURE'S CLINICAL TEAM INVESTIGATED THE EVENT AND CONFIRMED USER ERROR WAS INVOLVED. PHOTOS OF THE PATIENT WAS PROVIDED AND CLINICAL DETERMINED PATIENT WAS INCORRECTLY ASSESSED. PATIENT'S FITZPATRICK APPEARS TO BE FITZ IV BUT WAS ASSESSED AS FITZ VI. SITE DID NOT PERFORM A TEST SPOT PRIOR TO TREATMENT ALTHOUGH RECOMMENDED PER LABELING. LABELING ALSO INSTRUCTS: LARGER SPOT SIZES WITH LOWER FLUENCE SHOULD BE USED IN HIGHLY PIGMENTED TATTOOS, AS WELL AS WITH TATTOOS ON EXTREMITIES. SITE PERFORMED TREATMENT WITH 4MM TIP ON INK THAT WAS DENSE AND BLACK. CYNOSURE MEDICAL DIRECTOR ALSO REVIEWED THE INCIDENT AND SUSPECTS SPOT SIZE WAS TOO SMALL GIVEN THE DENSE BLACK INK AND THE FITZPATRICK OF THE PATIENT. PER CYNOSURE MEDICAL DIRECTOR: PATIENT'S WRIST HAS PARTIAL THICKNESS BURN AND FLANK FULL THICKNESS BURNS. SOME LEVEL OF SCARRING IS EXPECTED. PATIENT IS ADVISED TO FOLLOW UP WITH SOMEONE SKILLED WITH BURN TREATMENT. PATIENT WAS GIVEN BACITRACIN AND TOPICAL SILVADENE AS PREVENTATIVE MEDICATION. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. COMPLIMENTARY VIRTUAL TRAINING WAS DISPATCHED TO THE SITE. BURNS ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS, HOWEVER PERMANENT SCARRING IS A LIKELY OUTCOME AND THEREFORE REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND PATIENT EXPERIENCED A BURN FOLLOWING A TATTOO REMOVAL TREATMENT USING PICOSURE. FIRST PATIENT WAS REPORTED IN MDR# 1222993-2024-00017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685992 PICOSURE PICOSURE GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other