BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3131093 · Received May 23, 2013

    Report

    Report Number
    3005113652-2013-00061
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. DEVICE LABELING: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING. POSTMARKET SURVEILLANCE: ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE; INFLAMMATION AT THE INJECTION SITE, ALLERGIC REACTIONS, BLISTER, INFECTION AT THE INJECTION SITE, SKIN RASH, BLEEDING ALL THE INJECTION-SITE, NECROSIS AT THE INJECTION SITE, ABSCESS AT THE INJECTION SITE, AND HEADACHE. INFLAMMATION AT THE INJECTION SITE, MOSTLY A NONSERIOUS EVENT, HAS BEEN REPORTED IN ASSOCIATION WITH EDEMA, ERYTHEMA, ECCHYMOSIS, PRURITUS, INDURATION, PAIN, NODULE, ABSCESS, AND INFECTION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS AND MARIONETTE LINES, THE PT EXPERIENCED "RED ERYTHEMA, ITCHY, TIGHT FEELING" FIVE DAYS LATER, AT THE INJECTION SITES. THE PT RECEIVED PRETREATMENT WITH ALCOHOL AND ANESTHESIA IN THE FORM OF "A THIN COAL OF BENZOCAINE/LIDOCAINE/TETRACAINE TOPICAL CREAM". AN ICE PACK WAS GIVEN TO THE PT IMMEDIATELY AFTER INJECTION. THE PT'S SYMPTOMS WERE TREATED WITH PREDNISONE AND DECADRON. THE HEALTHCARE PROFESSIONAL BELIEVED IT WAS MOST LIKELY AN ALLERGIC RESPONSE AND NOT A BIOFILM, BUT THE PHYSICIAN ALSO PRESCRIBED BACTRIM AS A PRECAUTION. PT'S SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230455 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA20128

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention JUVEDERM INJECTION| BENZOCAINE| AN ALCOHOL SWAB| TELRACAINE TOPICAL CREAM| LIDOCAINE