BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3003959 · Received March 12, 2013

    Report

    Report Number
    3005113652-2013-00009
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: 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. DEVICE LABELING: CONTRAINDICATIONS: JUVEDERM ULTRA PLUS XC IS CONTRAINDICATED FOR PATIENTS WITH SEVERE ALLERGIES MANIFESTED BY A HISTORY OF ANAPHYLAXIS OR HISTORY OR PRESENCE OF MULTIPLE SEVERE ALLERGIES. JUVEDERM ULTRA PLUS XC CONTAINS TRACE AMOUNTS OF GRAM-POSITIVE BACTERIAL PROTEINS AND IS CONTRAINDICATED FOR PATIENTS WITH A HISTORY OF ALLERGIES TO SUCH MATERIAL. JUVEDERM ULTRA PLUS XC CONTAINS TRACE AMOUNTS OF LIDOCAINE AND IS CONTRAINDICATED FOR PATIENTS WITH A HISTORY OF ALLERGIES TO SUCH MATERIAL. WARNINGS: INJECTION PROCEDURE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS STARTING EARLY AFTER TREATMENT AND LASTING <7 DAYS DURATION. ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AFTER APPLICATION AND REMOVAL OF BENZOCAINE/ LIDOCAINE/TETRACAINE NUMBING CREAM AND SUBSEQUENT INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE LIPS, THE PATIENT'S LIPS, CHEEKS, AND FACE BECAME SWOLLEN AND ITCHY WITHIN "15 MINUTES TO THREE TIMES THEIR SIZE." THE PHYSICIAN DIAGNOSED AND ALLERGIC REACTION. THE PATIENT WAS TREATED WITH HYALURONIDASE, BENADRYL INTRAMUSCULARLY, DECADRON INTRAMUSCULARLY, ORAL VALIUM, AN ICE PACK, AND SENT TO THE EMERGENCY ROOM FOR MONITORING. THE PATIENT SPENT AN HOUR IN THE EMERGENCY ROOM DURING WHICH NO ADDITIONAL TREATMENT WAS PROVIDED AND WAS RELEASED WHEN STABILIZED. BY THE NEXT DAY THE PATIENT'S SYMPTOMS HAD RESOLVED. INITIALLY, THE INJECTING PHYSICIAN EXONERATED THE DEVICE BELIEVING THE BENZOCAINE/ LIDOCAINE/ TETRACAINE NUMBING CREAM APPLIED IMMEDIATELY PRIOR TO THE INJECTION OF JUVEDERM ULTRA PLUS TO BE THE CAUSE OF THE PATIENT'S ALLERGIC REACTION. HOWEVER, APPROXIMATELY ONE MONTH AFTER THE INJECTION WITH JUVEDERM ULTRA PLUS XC, THE INJECTING PHYSICIAN CONDUCTED AN ALLERGY SKIN TEST FROM WHICH THE INJECTING PHYSICIAN CONCLUDED THAT THE PATIENT WAS ALLERGIC TO JUVEDERM AND NOT THE BENZOCAINE/LIDOCAINE/TETRACAINE NUMBING CREAM OR LIDOCAINE 1% PLAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103157 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30L837072

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention "DIET PILLS"