BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 4142890 · Received September 23, 2014

    Report

    Report Number
    3005113652-2014-00467
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 14, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTERS REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT 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. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTION: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. POST MARKET SURVEILLANCE: THE FOLLOWING ADVERSE EVENTS WERE RECEIVED FROM POSTMARKET SURVEILLANCE FOR JUVEDERM ULTRA (WITHOUT LIDOCAINE), WHERE WERE NOT OBSERVED IN THE CLINICAL TRIALS; THIS INCLUDES REPORTS RECEIVED GLOBALLY FORM ALL SOURCES INCLUDING SCIENTIFIC JOURNALS AND VOLUNTARY REPORTS. ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE: ALLERGIC REACTION, BLISTER, INFLAMMATION AT THE INJECTION SITE, PARESTHESIA, INFECTION AT THE INJECTION SITE, BLEEDING AT THE INJECTION SITE, SKIN RASH, MALAISE, HEADACHE, BLANCHING, VISION ABNORMALITIES, ABSCESS AT THE INJECTION SITE, URTICARIA, HERPES SIMPLEX, TELANGIECTASIS, ANGIOEDEMA, FLU-LIKE SYMPTOMS, NAUSEA, VASCULAR EVENT, DYSPNEA, DERMATITIS, GRANULOMA AT THE INJECTION SITE, AND SCAR.

    Description of Event or Problem · 1

    PATIENT REPORTED APPROX 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. APPROX 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 JUVEDERM PRODUCT THAT HAD BEEN INJECTED". FOLLOW UP WITH THE INJECTING HEALTHCARE PROFESSIONAL NOTED APPROX 3 MONTHS AFTER INJECTION WITH 1 SYRINGE OF JUVEDERM ULTRA XC IN THE "CORNERS OF THE MOUTH" AS WELL AS CONCOMITANT INJECTION OF 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS, BILATERAL "PRE JOWL FOCUS", "ANGLE OF THE MANDIBLE", ABOVE LATERAL EYE BROWS, AND LEFT PROXIMAL NASOLABIAL FOLD THE PATIENT UNDERWENT A ROOT CANAL. "SHORTLY AFTER" THE PROCEDURE, THE PATIENT'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. APPROX 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 JOWL FOCUS". THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2014-00466 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVEDERM ULTRA XC, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590879 JUVEDERM ULTRA XC TSK US LMH LMH ALLERGAN NA H24LA30355

    Patients

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