BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONYCA LIDOCAINE, 2X1.25ML

    MDR report key: 22215922 · Received June 16, 2025

    Report

    Report Number
    3005113652-2025-00566
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    March 26, 2024
    Report Date
    June 16, 2025
    Manufacturer
    PANAXIA LTD
    Product Code
    LMH
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 3005113652-2024-0011046. 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. ABBVIE IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL; THEREFORE, ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A CLINICAL PATIENT WAS INJECTED IN THE CHEEKS BILATERALLY WITH 2.3ML OF HARMONYCA LIDOCAINE. ABOUT ONE MONTH LATER THE PATIENT RECEIVED TOUCH-UP INJECTIONS WITH 1.1ML OF HARMONYCA LIDOCAINE. THE PATIENT WAS CONCOMITANTLY TREATED WITH TOPICAL PRE-TREATMENT ANESTHESIA AND CONCOMITANTLY TAKES AMLODIPINE, FUROATE, MOMETASONE, CITALOPRAM, BETADERM, AND IRBESARTAN. APPROXIMATELY SEVEN MONTHS AND A HALF AFTER THE TOUCH-UP INJECTIONS THE PATIENT EXPERIENCED NON DEVICE RELATED ¿HERNIA¿. ABOUT THREE WEEKS LATER THE PATIENT HAD A HERNIA SURGERY AND WAS TREATED WITH HYDROMORPHONE . THE EVENT RESOLVED THE SAME DAY. 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, TOUCH-UP INJECTIONS OF HARMONYCA LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987630 HARMONYCA LIDOCAINE, 2X1.25ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD 0452202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R AMLODIPINE.| BETADERM.| CITALOPRAM.| FUROATE.| IRBESARTAN.| MOMETASONE.