BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 21756244 · Received April 2, 2025

    Report

    Report Number
    3005113652-2025-00299
    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. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6), (EMDR-(B)(4), (B)(6), (EMDR(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, INITIAL INJECTION OF HARMONYCA WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744911 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male