BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY

    MDR report key: 17644820 · Received August 29, 2023

    Report

    Report Number
    3020704367-2023-00017
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    December 29, 2022
    Report Date
    August 29, 2023
    Manufacturer
    CYTRELLIS BIOSYSTEMS, INC
    Product Code
    QAI
    PMA / PMN Number
    K202517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE THAT THE DEVICE CONTRIBUTED TO THE ADVERSE EVENT. HOWEVER, IF WE ARE MADE AWARE OF NEW INFORMATION WE WILL REASSESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAS PIH 8 MONTHS AFTER TREATMENT AND ISSUE IS NOT RESLOVED. PATIENT SOUGHT MEDICAL INTERVENTION INCLUDING FRACTIONAL LASERS AND PICO LASER TECHNOLOGY WHICH STILL HAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085461 ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY MICRO-CORING TECHNOLOGY QAI CYTRELLIS BIOSYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Required Intervention