BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBLS

    MDR report key: 22420637 · Received July 7, 2025

    Report

    Report Number
    2953696-2025-00045
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 22, 2025
    Manufacturer
    SCITON INC.
    Product Code
    GEX
    UDI-DI
    00863249000312
    PMA / PMN Number
    K070388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 1: NEW INFORMATION RECEIVED NOTES THAT THE PATIENT RETURNED FOR A FOLLOW-UP CONSULTATION. THE PATIENT CONDITION IS IMPROVING, AND MATTER IS CONSIDERED RESOLVED.

    Additional Manufacturer Narrative · 0

    THE SCITON CLINICAL SPECIALIST EXPLAINED TO THE CLINIC THAT THE INCREASED UV EXPOSURE DURING THIS SEASON MAY HAVE CONTRIBUTED TO A HEIGHTENED SKIN REACTION DUE TO POSSIBLE TANNING. ON (B)(6) 2025: SCITON CLINICAL SPECIALIST FOLLOWED UP WITH THE CLINIC, AND IT WAS REPORTED THAT THE PATIENT HAS NOT RETURNED FOR A CONSULTATION. THE CLINIC INFORMED THE PATIENT THAT A FOLLOW-UP VISIT IS NOT NECESSARY UNLESS THE SYMPTOMS WORSEN. THEY ALSO MENTIONED THAT THEY HAVE NOT RECEIVED ANY FURTHER CALLS OR INQUIRIES FROM THE PATIENT.

    Description of Event or Problem · 0

    PATIENT: 70S AGE. PATIENT SKIN TYPE: IV. TREATMENT DATE: ON (B)(6) 2025. TREATMENT PERFORMED BY: NURSE. TREATMENT DETAILS: FULL-FACE TREATMENT. FILTER: 590. FLUENCE: 9 J/CM². PULSE WIDTH: 20 MSEC. COOLING: 15°C. ADAPTER: 15×15. SHOTS: 155. SPOT TREATMENT FOR PIGMENTED LESIONS. FILTER: 560. FLUENCE: INITIALLY 11 J. PULSE WIDTH: 15-20 MSEC. DUE TO PATIENT-REPORTED PAIN, FLUENCE WAS REDUCED TO 10 J DURING THE PROCEDURE. TOTAL SPOT TREATMENT SHOTS: 52. ADVERSE EVENT DESCRIPTION: IT WAS REPORTED THAT IMMEDIATELY AFTER THE PROCEDURE, INTENSE "POPPING" RESPONSES WERE OBSERVED ON THE HEAVILY PIGMENTED LESIONS TREATED WITH THE 560 FILTER. THOSE AREAS BECAME NOTICEABLY DARKER, AND BLISTER FORMATION OCCURRED. THE PATIENT WAS PRESCRIBED DEXAMETHASONE PROPIONATE 0.1% (MESADERM 0.1%), BUT NO FOLLOW-UP VISIT HAS TAKEN PLACE TO DATE. THE PREVIOUS TREATMENT ON (B)(6) 2025, USED THE SAME PARAMETERS. AFTER THAT SESSION, THE PATIENT REPORTED INCREASED PIGMENTATION. THE CAUSE WAS PRESUMED TO BE POST-TREATMENT SUN EXPOSURE AND/OR FRICTION, RESULTING IN PIH (POST-INFLAMMATORY HYPERPIGMENTATION).

    Description of Event or Problem · 0

    PATIENT: 70'S AGE, PATIENT SKIN TYPE: IV, TREATMENT DATE: (B)(6) 2025, TREATMENT PERFORMED BY: NURSE. TREATMENT DETAILS: FULL-FACE TREATMENT. FILTER: 590. FLUENCE: 9 J/CM². PULSE WIDTH: 20 MSEC. COOLING: 15°C. ADAPTER: 15×15. SHOTS: 155. SPOT TREATMENT FOR PIGMENTED LESIONS. FILTER: 560. FLUENCE: INITIALLY 11 J. PULSE WIDTH: 15-20 MSEC. DUE TO PATIENT-REPORTED PAIN, FLUENCE WAS REDUCED TO 10 J DURING THE PROCEDURE. TOTAL SPOT TREATMENT SHOTS: 52. ADVERSE EVENT DESCRIPTION: IT WAS REPORTED THAT IMMEDIATELY AFTER THE PROCEDURE, INTENSE "POPPING" RESPONSES WERE OBSERVED ON THE HEAVILY PIGMENTED LESIONS TREATED WITH THE 560 FILTER. THOSE AREAS BECAME NOTICEABLY DARKER, AND BLISTER FORMATION OCCURRED. THE PATIENT WAS PRESCRIBED DEXAMETHASONE PROPIONATE 0.1% (MESADERM 0.1%), BUT NO FOLLOW-UP VISIT HAS TAKEN PLACE TO DATE. THE PREVIOUS TREATMENT ON (B)(6) 2025, USED THE SAME PARAMETERS. AFTER THAT SESSION, THE PATIENT REPORTED INCREASED PIGMENTATION. THE CAUSE WAS PRESUMED TO BE POST-TREATMENT SUN EXPOSURE AND/OR FRICTION, RESULTING IN PIH (POST-INFLAMMATORY HYPERPIGMENTATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152871 BBLS IPL DEVICE GEX SCITON INC. BBLS 31075 00863249000312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention