BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 15566143 · Received October 7, 2022

    Report

    Report Number
    3005113652-2022-00669
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    June 23, 2022
    Report Date
    January 3, 2023
    Manufacturer
    PANAXIA LTD
    Product Code
    LMH
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 COVID-19 INFECTION, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN ¿THE ZYGOMATIC ARCH, CONTOUR OF THE MANDIBLE AND PRE-AURICULAR REGION, ORIENTED AREAS¿ WITH 2 SYRINGES, ONE PER SIDE OF HARMONYCA¿ WITH LIDOCAINE. TWO WEEKS AFTER THE PROCEDURE, PATIENT HAD COVID-19, DEEMED NOT DEVICE RELATED. THE PATIENT WAS TREATED WITH KOIDE D AND COLCHICINE. APPROXIMATELY 3 MONTHS POST INJECTIONS THE PATIENT EXPERIENCED, ¿HARDENED AND VISIBLE NODULES AND THE PATIENT IS VERY ANXIOUS¿. THE PATIENT WAS REFERRED TO HAVE AN ¿ULTRASOUND EXAMINATION."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN ¿THE ZYGOMATIC ARCH, CONTOUR OF THE MANDIBLE AND PRE-AURICULAR REGION, ORIENTED AREAS¿ WITH 2 SYRINGES, ONE PER SIDE OF HARMONYCA¿ WITH LIDOCAINE. TWO WEEKS AFTER THE PROCEDURE, PATIENT HAD COVID-19, DEEMED NOT DEVICE RELATED. THE PATIENT WAS TREATED WITH KOIDE D AND COLCHICINE. APPROXIMATELY 3 MONTHS POST INJECTIONS THE PATIENT EXPERIENCED, ¿HARDENED AND VISIBLE NODULES AND THE PATIENT IS VERY ANXIOUS¿. THE PATIENT WAS REFERRED TO HAVE AN ¿ULTRASOUND EXAMINATION."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN ¿THE ZYGOMATIC ARCH, CONTOUR OF THE MANDIBLE AND PRE-AURICULAR REGION, ORIENTED AREAS¿ WITH 2 SYRINGES, ONE PER SIDE OF HARMONYCA¿ WITH LIDOCAINE. TWO WEEKS AFTER THE PROCEDURE, PATIENT HAD COVID-19, DEEMED NOT DEVICE RELATED. THE PATIENT WAS TREATED WITH KOIDE D AND COLCHICINE. APPROXIMATELY 3 MONTHS POST INJECTIONS THE PATIENT EXPERIENCED, ¿HARDENED AND VISIBLE NODULES AND THE PATIENT IS VERY ANXIOUS¿. THE PATIENT WAS REFERRED TO HAVE AN ¿ULTRASOUND EXAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289066 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD 2292102

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention BOTOX® AND ULTRAFORMER.