BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 2810040 · Received October 23, 2012

    Report

    Report Number
    3005113652-2012-00100
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(4) 2012. DEVICE EVALUATION SUMMARY: BATCH NUMBER H30L805280 WAS RELEASED BY QC ACCORDING TO DEFINED SPECIFICATIONS. THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC TSK US, IN THE GLABELLA AND NASOLABIAL FOLDS, THE PATIENT EXPERIENCED "REDNESS AND SWOLLENNESS." BENADRYL AND A MEDROL DOSE PACK WERE USED TO PREVENT WORSENING OF THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30L805280

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R