BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONYCA LIDOCAINE, 2X1.25ML

    MDR report key: 22572993 · Received July 22, 2025

    Report

    Report Number
    3005113652-2025-00671
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    December 1, 2023
    Report Date
    July 22, 2025
    Manufacturer
    PANAXIA LTD
    Product Code
    LMH
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF AUTOIMMUNE DISORDER (VITILIGO) IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH HARMONYCA¿ LIDOCAINE AND DEVELOPED GRANULOMAS 9 DAYS AFTER 2 SYRINGES ON EACH SIDE. APPARITION OF SENSITIVE TO TOUCH NODULES ON INJECTION SITES, 2 AND HALF MONTHS AFTER THE INJECTION. THE NODULES ARE NOT VISIBLE. NO BIOPSY PERFORMED. PATIENT REPORTED VIA REGULATORY AGENCY THAT THEY HAVE A HISTORY OF VITILIGO BUT RECENTLY EXPERIENCED ¿MULTIPLIES VERY MUCH QUICKLY,¿ AND THE PATIENT EXPERIENCED A ¿HEADACHE¿ THAT MAY BE DUE TO HIGH BLOOD PRESSURE, DEEMED NOT DEVICE RELATED. THE PATIENT WAS PLACED ON A TREATMENT THAT THEY ¿DID NOT TOLERATE WELL.¿ SYMPTOMS ON GOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER: (B)(6) (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT LOT NUMBER: 1862203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725661 HARMONYCA LIDOCAINE, 2X1.25ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD 1862203

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention