BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 20043688 · Received August 22, 2024

    Report

    Report Number
    3005113652-2024-001105
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 1, 2023
    Report Date
    August 22, 2024
    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

    CONTINUED D.10. CONCOMITANT THERAPIES: IMMOVANE, LUPIN ESTRADIOL, PROMETRIUM. 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. THE EVENT OF TORN MENISCUS, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN THE CHEEKS BILATERALLY WITH 1.5ML OF HARMONYCA LIDOCAINE. TWELVE DAYS LATER, PATIENT WAS WALKING AND TRIPPED ON FOOT AND FELL. MRI PERFORMED SHOWED TORN MENISCUS, DEEMED NOT DEVICE RELATED. NEXT DAY, PATIENT EXPERIENCED HEADACHE, DEEMED NOT DEVICE RELATED AND SYMPTOM RESOLVED SAME DATE. A WEEK LATER, PATIENT WAS INJECTED WITH A TOUCH-UP TREATMENT BILATERALLY WITH 2.05ML OF HARMONYCA LIDOCAINE. PATIENT ALSO EXPERIENCED CONCUSSION, DEEMED NOT DEVICE RELATED. APPROXIMATELY FIVE AND A HALF MONTHS LATER, PATIENT HAD SURGERY TO REPAIR TORN MENISCUS. TWELVE DAYS LATER, PATIENT EXPERIENCED NON DEVICE RELATED "COLD VIRUS" WHICH WAS TREATED WITH COUGH SYRUP AND NIGHT QUILL AND RESOLVED ELEVEN DAYS LATER. TWENTY DAYS AFTER THE TOUCH-UP TREATMENT THE PATIENT EXPERIENCED NON DEVICE RELATED "COVID-19 INFECTION" AND RESOLVED TWENTY DAYS LATER. APPROXIMATELY ONE YEAR AND FOUR MONTHS LATER THE PATIENT EXPERIENCED NON DEVICE RELATED ¿FALL OFF STEP LADDER DUE TO SLIPPER FALLING OFF AND SHOULDER PAIN DUE TO FALL OFF STEP LADDER.¿ THE SHOULDER PAIN IS ONGOING. THE BACK PAIN AND TORN MENISCUS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR #3005113652-2024-0011055 (ALLERGAN COMPLAINT # (B)(4) ). THIS MDR IS BEING SUBMITTED FOR THE 2ND INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363961 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention PRE-TREATED WITH TOPICAL ANESTHESIA, BOTOX®.