BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1 ML

    MDR report key: 4142793 · Received September 23, 2014

    Report

    Report Number
    3005113652-2014-00466
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTERS REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE THIS TIME. THE EVENT OF LUMPS, INFECTION, SWELLING, TENDERNESS, BRUISING, AND FIRMNESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT REPORTED APPROXIMATELY 4 MONTHS AFTER INJECTION WITH UNSPECIFIED JUVEDERM IN THE CHEEKS THE PATIENT UNDERWENT A BILATERAL ROOT CANAL TO TREAT AN UNRELATED INFECTION. IMMEDIATELY AFTER THE ROOT CANAL, THE PATIENT'S FACE BECAME "SWOLLEN AND TENDER", WHICH THE ENDODONTIST STATED WERE NORMAL SYMPTOMS POST-ROOT CANAL. APPROXIMATELY 1 MONTH AFTER THE ROOT CANAL, THE PATIENT DEVELOPED SWELLING UNDERNEATH THE RIGHT EYE AND LEFT LOWER CHEEK AS WELL AS A "BIG HARD LUMP" AT THE RIGHT JUVEDERM INJECTION SITE. THE PATIENT PUT ICE ON THE SYMPTOM SITES AND WAS ASSESSED BY THE ENDODONTIST. THE ENDODONTIST INFORMED THE PATIENT THAT THE "INFECTION HAD BEEN STIRRED UP FROM THE ROOT CANAL AND REACTED WITH THE JUVERERM PRODUCT THAT HAD BEEN INJECTED". FOLLOW UP WITH THE INJECTING HEALTHCARE PROFESSIONAL NOTED APPROXIMATELY 3 MONTHS AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS, RIGHT AND LEFT PRE "JOWL FOCUS", ANGLE OF THE MANDIBLE", ABOVE THE LATERAL EYEBROWS, AND LEFT PROXIMAL NASOLABIAL FOLD AS WELL AS CONCOMITANT INJECTION OF JUVEDERM ULTRA XC IN THE "CORNERS OF THE MOUTH" THE PATIENT UNDERWENT A ROOT CANAL. "SHORTLY AFTER" THE PROCEDURE, THE PAITENT'S FACE BECAME SWOLLEN AND TENDER, WHICH THE INJECTING HEALTHCARE PROFESSIONAL BELIEVED TO BE INFECTIOUS FACIAL CELLULITIS. THE PATIENT WAS PRESCRIBED AUGMENTIN FOR THESE SYMPTOMS, WHICH THE INJECTOR DID NOT BELIEVE WERE RELATED TO THE JUVEDERM INJECTIONS BUT THE RESULT OF THE ROOT CANAL. APPROXIMATELY TWO WEEKS AFTER SYMPTOM PRESENTATION THE PATIENT DISCONTINUED THE AUGMENTIN; TWO WEEKS LATER, THE PATIENT DEVELOPED NODULES, BRUISING, AND SWELLING AT ALL THE AREAS WHERE BOTH JUVEDERM VOLUMA XC AND JUVEDERM ULTRA XC HAD BEEN INJECTED. THE PATIENT SUBSEQUENTLY RESUMED THE AUGMENTIN TREATMENT; THE INJECTING HEALTHCARE PROFESSIONAL ADVISED THE PATIENT TO CONTINUE TAKING THE ANTIBIOTIC FOR 6 WEEKS. DURING A FOLLOW UP APPOINTMENT FIVE WEEKS AFTER AUGMENTIN TREATMENT RESUMED, THE HEALTHCARE PROFESSIONAL NOTED ALL OF THE PATIENT'S SYMPTOMS HAD RESOLVED, WITH THE EXCEPTION OF "MINOR NODULES WITH FIRMNESS AT THE BILATERAL PRE JOWEL FOCUS". THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2014-00467 (ALLERGAN COMPLAINT PR# (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590970 JUVEDERM VOLUMA XC 27G 2 X 1 ML LMH ALLERGAN NA VB20A40006

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention JUVEDERM ULTRA XC