BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VOLBELLA

    MDR report key: 9458917 · Received December 12, 2019

    Report

    Report Number
    3005113652-2019-00850
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 21, 2013
    Report Date
    March 13, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B.5., B.6., G.1.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED TO ¿HAVE THE PATHOLOGY REPORT ON THE PATIENT." THE BIOPSY WAS PERFORMED 5 DAYS AFTER THE LAST INJECTION. GRANULOMA WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS 2ML JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE INJECTION TO CHEEKS, NLFS AND MARIONETTE ZONE. PATIENT EXPERIENCED DELAYED-ONSET NODULES AT L NLF, L MEDIAL CHEEK AND BOTH MARIONETTES 3 MONTHS LATER. POTENTIAL TRIGGER NOTED AS DENTAL IMPLANTS (FRONT 4 TEETH) APPLIED IMMEDIATELY BEFORE SYMPTOMS APPEARED. 2 WEEKS OF ANTIBIOTICS WITH DENTAL SURGERY ALSO NOTED. HA 75 UNITS/ML X 2ML AND MINOCIN 100MG/D X 2 MONTHS PROVIDED AS TREATMENT ONE MONTH AFTER SYMPTOM APPARITION. THE SWELLING AND NODULARITY RECEDED ABOUT A MONTH LATER. "PERSISTING MARIONETTE ZONES, L SIDE UPPER LIP, LATERAL CHEEKS" NOTED. EVENT RESOLVED EXCEPT FOR CENTRAL UPPER LIP THE NEXT MONTH AFTER HA 75 UNITS/ML APPLIED TO UPPER LIP CENTRALLY. 2 MONTHS LATER, 1 ML JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE APPLIED TO UPPER LIP (0.25ML), TEAR TROUGHS (0.6ML TOT), LIP CORNERS (0.15ML TOT). RENEWED SWELLING OCCURRED AT L CHEEK AND R NLF WITHIN 24 HOURS OF ADDITIONAL JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE INJECTION THE FOLLOWING MONTH. HA 75 UNITS/ML X 0.6ML (0.4ML TO LEFT CHEEK) ADMINISTERED AT THAT TIME. "MORE TREATMENTS" NOTED- BUT "NO FURTHER MENTION OF GRANULOMAS." THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2019-00848 (2050609) AND MDR ID# 3005113652-2019-00849 (2050613). THIS MDR IS BEING SUBMITTED FOR THE SECOND INJECTION OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253090 UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention