BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 21756063 · Received April 2, 2025

    Report

    Report Number
    3005113652-2025-00298
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 2, 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

    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. THE EVENT OF "DETACHED RETINAS", DEEMED NOT DEVICE RELATED, IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A CLINICAL PATIENT WAS INJECTED IN THE CHEEKS BILATERALLY WITH 6ML OF HARMONYCA WITH LIDOCAINE. APPROXIMATELY ONE MONTH LATER, THE PATIENT RECEIVED TOUCH-UP INJECTIONS WITH 2.4ML OF HARMONYCA WITH LIDOCAINE. ABOUT ONE YEAR AND EIGHT MONTHS LATER, THE PATIENT RECEIVED A REPEAT TREATMENT WITH 5ML OF HARMONYCA WITH LIDOCAINE. ABOUT TWO WEEKS AFTER THE LAST INJECTIONS THE PATIENT EXPERIENCED NON DEVICE RELATED ¿BILATERAL DETACHED RETINAS FROM COUGHING.¿ NO TREATMENT WAS PROVIDED. THE EVENT RESOLVED ABOUT A MONTH LATER. THE PATIENT CONCOMITANTLY TAKES; VITAMIN E, OMEGA 3, CREATINE, 5-HTP, WHEY PROTEIN, ALLMAX AMINO ACID BLEND, ALLMAX ZMX ZINC MAGNESIUM VITAMIN B6, AND AMLODIPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372632 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male