BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONYCA LIDOCAINE, 2X1.25ML

    MDR report key: 16718920 · Received April 11, 2023

    Report

    Report Number
    3005113652-2023-00297
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    September 16, 2022
    Report Date
    May 22, 2023
    Manufacturer
    PANAXIA LTD
    Product Code
    LMH
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO SECTION C. SUSPECT PRODUCT: LOT NUMBER RM 6003 LD 19E69-C.

    Additional Manufacturer Narrative · 0

    CONTINUED ADVERSE EVENT PROBLEM INVESTIGATION CODE: B11, B12, B15. CLARIFICATION TO ADVERSE EVENT PROBLEM TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. ALLERGAN 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. THE EVENT OF INFECTION, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2.5 ML OF HARMONYCA INTO THE RIGHT ZYGOMATIC ARCH AND ANGLE MANDIBLE AND 1.75 ML WERE INJECTED INTO THE LEFT ZYGOMATIC ARCH AND ANGLE MANDIBLE. ON THAT SAME DAY, PATIENT EXPERIENCED NUMBNESS AT THE INJECTION SITE OF THE LOWER JAW THAT WAS MODERATE, NEEDED NO TREATMENT, AND RESOLVED THE NEXT DAY. PATIENT LATER EXPERIENCED MILD HEMATOMA ON LEFT AND RIGHT CHEEKBONES THAT IS ONGOING AND NOT BEEN PROVIDED TREATMENT. ABOUT TWO WEEKS AFTER THE INITIAL INJECTION, PATIENT WAS INJECTED WITH ANOTHER 0.45 ML OF HARMONYCA WITH LIDOCAINE INTO THE LEFT ZYGOMATIC ARCH. THE NEXT DAY, PATIENT EXPERIENCED A MILD HEADACHE THAT WAS NOT RELATED TO THE DEVICE THAT LASTED FOR THREE HOURS. IT WAS TREATED WITH A DOSE OR ORAL PARACETAMOL. ABOUT THREE MONTHS AFTER THE FIRST INJECTION, PATIENT WOULD FALL A DISTANCE OF APPROXIMATELY THEIR OWN HEIGHT DUE TO CLUMSINESS AND DEVELOPED A LEFT ANTERIOR TIBIAL WOUND. A SUPERINFECTION WOULD DEVELOP IN THE TIBIAL WOUND ABOUT TWO WEEKS AFTER THE FALL OCCURRED. PATIENT WAS TREATED WITH ORAL AMOXICILLIN FOR 15 DAYS. THIS FALL, SUBSEQUENT INJURY, AND INFECTION WERE NOT RELATED TO THE DEVICE. ABOUT A WEEK AFTER THE INFECTION RESOLVED, PATIENT EXPERIENCED MILD "BUZZING OLD SCAR AT THE JUNCTION OF THE RIGHT LOWER PALM AND CHEEK". THIS EVENT IS CONSIDERED TO BE MILD, POSSIBLY RELATED TO THE DEVICE AND ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00296 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF SUSPECT PRODUCT, HARMONYCA WITH LIDOCAINE.

    Description of Event or Problem · 0

    ADDITIONAL DETAILS RECEIVED NOTING THE EVENT "BUZZING OLD SCAR AT THE JUNCTION OF THE RIGHT LOWER PALM AND CHEEK" WAS CLARIFIED AS "SWELLING OLD SCAR AT THE JUNCTION OF THE RIGHT LOWER PALM AND CHEEK".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 2.5 ML OF HARMONYCA INTO THE RIGHT ZYGOMATIC ARCH AND ANGLE MANDIBLE AND 1.75 ML WERE INJECTED INTO THE LEFT ZYGOMATIC ARCH AND ANGLE MANDIBLE. ON THAT SAME DAY, PATIENT EXPERIENCED NUMBNESS AT THE INJECTION SITE OF THE LOWER JAW THAT WAS MODERATE, NEEDED NO TREATMENT, AND RESOLVED THE NEXT DAY. PATIENT LATER EXPERIENCED MILD HEMATOMA ON LEFT AND RIGHT CHEEKBONES THAT IS ONGOING AND NOT BEEN PROVIDED TREATMENT. ABOUT TWO WEEKS AFTER THE INITIAL INJECTION, PATIENT WAS INJECTED WITH ANOTHER 0.45 ML OF HARMONYCA WITH LIDOCAINE INTO THE LEFT ZYGOMATIC ARCH. THE NEXT DAY, PATIENT EXPERIENCED A MILD HEADACHE THAT WAS NOT RELATED TO THE DEVICE THAT LASTED FOR THREE HOURS. IT WAS TREATED WITH A DOSE OR ORAL PARACETAMOL. ABOUT THREE MONTHS AFTER THE FIRST INJECTION, PATIENT WOULD FALL A DISTANCE OF APPROXIMATELY THEIR OWN HEIGHT DUE TO CLUMSINESS AND DEVELOPED A LEFT ANTERIOR TIBIAL WOUND. A SUPERINFECTION WOULD DEVELOP IN THE TIBIAL WOUND ABOUT TWO WEEKS AFTER THE FALL OCCURRED. PATIENT WAS TREATED WITH ORAL AMOXICILLIN FOR 15 DAYS. THIS FALL, SUBSEQUENT INJURY, AND INFECTION WERE NOT RELATED TO THE DEVICE. ABOUT A WEEK AFTER THE INFECTION RESOLVED, PATIENT EXPERIENCED MILD "BUZZING OLD SCAR AT THE JUNCTION OF THE RIGHT LOWER PALM AND CHEEK". THIS EVENT IS CONSIDERED TO BE MILD, POSSIBLY RELATED TO THE DEVICE AND ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00296 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF SUSPECT PRODUCT, HARMONYCA WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755769 HARMONYCA LIDOCAINE, 2X1.25ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD 0872202

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male