BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 19409878 · Received May 28, 2024

    Report

    Report Number
    3005113652-2024-001104
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    March 26, 2024
    Report Date
    May 28, 2024
    Manufacturer
    ALLERGAN (PRINGY)
    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: AMLODIPINE, FUROATE, MOMETASONE, CITALOPRAM, BETADERM, AND IRBESARTAN. CONTINUED H.6. HEALTH EFFECT - IMPACT CODES: F2303 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 HERNIA, 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 2.3ML OF HARMONYCA LIDOCAINE. ABOUT ONE MONTH LATER THE PATIENT RECEIVED TOUCH-UP INJECTIONS WITH 1.1ML OF HARMONYCA LIDOCAINE. THE PATIENT WAS CONCOMITANTLY TREATED WITH TOPICAL PRE-TREATMENT ANESTHESIA AND CONCOMITANTLY TAKES AMLODIPINE, FUROATE, MOMETASONE, CITALOPRAM, BETADERM, AND IRBESARTAN. APPROXIMATELY SEVEN MONTHS AND A HALF AFTER THE TOUCH-UP INJECTIONS THE PATIENT EXPERIENCED NON DEVICE RELATED ¿HERNIA¿. ABOUT THREE WEEKS LATER, PATIENT WAS HOSPITALIZED AND UNDERWENT A HERNIA SURGERY. PATIENT WAS ALSO TREATED WITH HYDROMORPHONE. THE EVENT RESOLVED THE SAME DAY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2024-0011046 (ABBVIE COMPLAINT # (B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400203 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R TOPICAL PRE-TREATMENT ANESTHESIA