BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4132700 · Received September 29, 2014

    Report

    Report Number
    3005113652-2014-00477
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF "REDNESS", "PAIN", "SWELLING", "INFECTION", "HEAT", AND "FLUID BUILD-UP" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: AS WITH ALL TRANSCUTANEOUS PROCEDURES, DERMAL FILLER IMPLANTATION CARRIES A RISK OF INFECTION. STANDARD PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED. CLINICAL DATA: TREATMENT SITE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS AND GENERALLY RESOLVE WITHIN 2 TO 4 WEEKS. TWO SUBJECTS (0.7%; 2/270) REPORTED 3 SERIOUS ADVERSE EVENTS (SAES) THAT WERE CONSIDERED TO BE RELATED TO THE DEVICE. APPROXIMATELY 6 MONTHS AFTER TREATMENT, AFTER BEING SCRATCHED NEAR THE TREATMENT AREA BY A TREE BRANCH, ONE SUBJECT EXPERIENCED INFLAMMATION UNDER THE LEFT EYE. THE SUBJECT ALSO EXPERIENCED NODULARITY IN THE RIGHT CHEEK APPROXIMATELY 7 MONTHS AFTER TREATMENT. THE SECOND SUBJECT EXPERIENCED LUMPS IN THE CHEEKS APPROXIMATELY 7 MONTHS AFTER TREATMENT. A COUPLE OF DAYS BEFORE THE ONSET, THE SUBJECT EXPERIENCED MYOFASCIAL PAIN AND BODY ACHES. TREATMENT OF THE SAES INCLUDED TOPICAL STEROIDS, ORAL ANTIBIOTICS, INTRALESIONAL STEROIDS, ANTI-INFLAMMATORY MEDICATION, AND HYALURONIDASE. ALL EVENTS RESOLVED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT APPROXIMATELY ONE MONTH AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE "MALAR AND CHEEK BONE AREA," THE PATIENT EXPERIENCED "REDNESS, PAIN, SWELLING, INFECTION AND HEAT AT THE INJECTION SITE." TWO DAYS LATER, PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED DOXYCYCLINE. TWO WEEKS LATER, THE HEALTHCARE PROFESSIONAL SAW THE PATIENT AND OBSERVED A "SUPERFICIAL INFECTION OF THE FACE" AND "FLUID BUILD-UP IN THE RIGHT MAXILLA." HEALTHCARE PROFESSIONAL ASPIRATED THE AFFECTED AREA AND DRAINED THE AREA OF "INFECTED FLUID." THIS WAS DONE ON SEVERAL OCCASIONS. CULTURES DONE ON THE FLUID ALL CAME BACK NEGATIVE. TWO DAYS AFTER THE INITIAL ASPIRATION, THE PATIENT HAD A ROOT CANAL PERFORMED BY AN UNSPECIFIED HEALTHCARE PROFESSIONAL DUE TO AN "INFECTED TOOTH IN THE MANDIBLE." PATIENT WAS PRESCRIBED CLEOCIN AFTER THE PROCEDURE. APPROXIMATELY TWO WEEKS LATER, PATIENT WENT BACK TO THE EMERGENCY ROOM AND WAS PRESCRIBED LEVOFALAXIN. ABOUT A WEEK AND A HALF LATER, PATIENT RETURNED TO THE INJECTING HEALTHCARE PROFESSIONAL AND WAS PRESCRIBED CIPROFALAXIN. INJECTING HEALTHCARE PROFESSIONAL SAW THE PATIENT ONE WEEK LATER AND SYMPTOMS HAD RESOLVED. HEALTHCARE PROFESSIONAL STATED THAT "GIVEN THE TIMELINE OF THE INFECTED TOOTH AND SUBSEQUENT ROOT CANAL, THERE IS NO WAY TO DETERMINE WHETHER THE SYMPTOMS WERE A RESULT OF THE JUVEDERM INJECTION, OR IF THE INJECTION WAS THE CAUSE OF THE INFECTION IN THE TOOTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604947 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A30431

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention FLUOXETINE, IRBESARTAN