BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 17564471 · Received August 17, 2023

    Report

    Report Number
    3005113652-2023-00657
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 9, 2023
    Report Date
    August 17, 2023
    Manufacturer
    PANAXIA LTD
    Product Code
    LMH
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D.4.: LOT NUMBER 2072203; CATALOG NUMBER F202. CLARIFICATION TO SECTION C. SUSPECT PRODUCT: LOT NUMBER LD- 20J82-C. CONTINUED H.6. TYPE OF INVESTIGATION CODE: B15, B17, B20. 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. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 OTITIS, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN THE LIPS WITH 2 VIALS JUVÉDERM® ULTRA 3. A YEAR LATER, PATIENT WAS INJECTED WITH JUVÉDERM® VOLUX¿ IN THE CHIN (C1, C2 AND C4), IN THE ZYGOMATIC, PREAURICULAR AND MANDIBUULAR LINE WITH 2 VIALS HARMONYCA WITH LIDOCAINE, IN THE CK1, CK2 Y CK3, NL1, NL2 AND NL3 WITH 2 VIALS JUVÉDERM® ULTRA 4. APPROXIMATELY 5 WEEKS LATER, PATIENT EXPERIENCED AN OTITIS, DEEMED NOT DEVICE RELATED, TREATED WITH ANTIBIOTIC DROPS. A WEEK LATER, PATIENT EXPERIENCED ¿LOTS OF PAIN IN THE CHIN AREAS AT TALKING, GESTICULATING AND EATING.¿ HCP ¿NOTICED AN INDURATED LUMP AND DOES NOT REFER CHANGES IN COLOR OR CHANGES IN THE TEMPERATURE OF THE SKIN¿. THE PATIENT¿S DENTIST ¿NOTICED AN ULCER (RECURRENT ACCORDING TO THE PATIENT) IN THE UNION OF THE MUCOUS MEMBRANE OF THE LOWER LIP WITH THE GUM OF THE LOWER INCISIVE TEETH¿ WHICH WAS NOT TREATED. IT WAS REPORTED, ¿THE PATIENT CARRIES DENTAL IMPLANTS WHICH HAVE DAMAGED IN OTHER OCCASIONS DUE TO BRUXISM (ONLY TREATED WITH A DISCHARGE SPLINT).¿ MOST RECENTLY, ¿AT PALPATION THE CHIN IS MILDLY INDURATED, ESPECIALLY IN THE UPPER AREA (C1) AND MILDLY PAINFUL AT DEEP PALPATION. INSIDE THE MOUTH IT IS SHOWN A PROTRUSION OF THE GUM, PAINFUL AT TOUCH, SOFT AT PALPATION¿. THE PATIENT ALSO REPORTED, ¿PAIN AGAIN, LESS THAN THE FIRST TIME¿, ¿NOTICING THE CHIN IS SOMEWHAT MORE INDURATED (NOT AS MUCH AS THE FIRST TIME)¿, ¿HAS HAD BAD NIGHTS DUE TO STRESS¿ AND ¿HAS BEEN CLENCHING HER JAW A LOT¿. TREATMENT INCLUDED PREDNISONE AND CIPROFLOXACINE. SYMPTOMS IMPROVED BUT NOT RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00649 (ABBVIE COMPLAINT #PR (B)(4)), MDR ID# 3005113652-2023-00632 (ABBVIE COMPLAINT #PR (B)(4)), MDR ID# 3005113652-2023-00643 (ABBVIE COMPLAINT #PR (B)(4)), MDR ID# 3005113652-2023-00648 (ABBVIE COMPLAINT #PR (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, HARMONYCA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197508 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PANAXIA LTD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention JUVÉDERM® VOLUX¿, JUVÉDERM® ULTRA 4