BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HARMONYCA LIDOCAINE

    MDR report key: 17930974 · Received October 13, 2023

    Report

    Report Number
    3005113652-2023-00810
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 12, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    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

    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. 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 BLURRED VISION IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN THE TEMPLE, ZYGOMATIC, AND JAWLINE WITH 2 SYRINGES OF HARMONYCA¿ WITH LIDOCAINE. THREE DAYS LATER, THE PATIENT REPORTED A LUMP THAT WAS VERY SWOLLEN AND GIVEN A VIGOROUS MASSAGE THAT DAY. TEN DAYS LATER, PATIENT REPORTED LUMP WAS SORE AND PAINFUL. PATIENT WAS ADVISED TO USE A WARM COMPRESS AND MASSAGE. A WEEK LATER, THE PATIENT TOOK PREDSIM 20 MG FOR 10 DAYS. THE SYMPTOM HAS BEEN IMPROVED. TWO WEEKS LATER, STERILE SALINE WAS DIRECTLY APPLIED ON THE LUMP WITH MECHANICAL DRAINAGE AND A YELLOW SECRETION AND BLOOD CAME OUT. THE PATIENT STARTED AZITHROMYCIN 1X A DAY FOR 5 DAYS AND DEXAMETHASONE 2X A DAY FOR DAYS. THE NODULE SHRANK. A WEEK LATER, PATIENT REPORTED TO HAVE A YELLOWISH LESION, AND REPORTS FEELING BLURRED VISION. THE SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717436 UNK HARMONYCA LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention