BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VOLBELLA

    MDR report key: 10000967 · Received April 27, 2020

    Report

    Report Number
    3005113652-2020-00219
    Event Type
    Injury
    Date Received
    April 27, 2020
    Date of Event
    January 1, 2018
    Report Date
    April 27, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5.

    Description of Event or Problem · 0

    PATIENT REPORTED VIA REGULATORY AGENCY, BEING INJECTED WITH JUVÉDERM VOLBELLA® XC. THREE YEARS LATER, THE PATIENT EXPERIENCED A ¿VIRUS¿ (THIS EVENT IS NOT DEVICE RELATED) AND THE FILLER ¿REACTED,¿ MAKING THE PATIENT ¿SWELL.¿ TWO YEARS LATER, THE PATIENT HAD A ¿LATE INFLAMMATORY REACTION.¿ PATIENT INDICATED THEY HAD "21 SHOTS OF DISSOLVENT". THE PATIENT WAS TREATED WITH TWO ANTIBIOTICS ("CIPRO", AND "DOXYCYCLINE") AND PREDNISONE. A CT SCAN WAS PERFORMED THAT ¿CONFIRMED THAT IT WAS FILLER REACTING.¿ SYMPTOMS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS IN RESPONSE TO FDA REPORT NUMBER MW 5093524. NO CONTACT INFORMATION WAS PROVIDED FOR THE PATIENT, THEREFORE ADDITIONAL EVENT, PRODUCT, AND/OR PATIENT DETAILS ARE NOT ATTAINABLE. 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

    PATIENT REPORTED VIA REGULATORY AGENCY, BEING INJECTED WITH JUVÉDERM VOLBELLA® XC. THREE YEARS LATER, THE PATIENT EXPERIENCED A ¿VIRUS¿ AND THE FILLER ¿REACTED,¿ MAKING THE PATIENT ¿SWELL.¿ TWO YEARS LATER, THE PATIENT HAD A ¿LATE INFLAMMATORY REACTION.¿ PATIENT INDICATED THEY HAD "21 SHOTS OF DISSOLVENT". THE PATIENT WAS TREATED WITH TWO ANTIBIOTICS ("CIPRO", AND "DOXYCYCLINE") AND PREDNISONE. A CT SCAN WAS PERFORMED THAT ¿CONFIRMED THAT IT WAS FILLER REACTING.¿ SYMPTOMS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465243 UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BENADRYL, ZYRTEC