BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 927275 · Received October 12, 2007

    Report

    Report Number
    3005113652-2007-00031
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    August 18, 2007
    Report Date
    September 13, 2007
    Manufacturer
    CORNEAL
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE DOCUMENTARY RESEARCH IN THE TWO BATCH FILES SHOWS THAT ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL, EXTRUSION FORCE AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN, STERILITY TEST, STERILIZATION CYCLE) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    TWO DAYS AFTER TREATMENT BELOW, THE CHEEK BONES WITH JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS, THE PATIENT PRESENTED WITH REDNESS, ITCHING, AND PAIN AT THE TREATMENT SITE. THE PATIENT TOLD THE PHYSICIAN THAT THE PRODUCT WAS EXTRUDING OUT OF THE INJECTION SITES AFTER TREATMENT. THE PHYSICIAN NOTED SCABBING AT TREATMENT SITE, BUT SAW NO EXTRUDING PRODUCT. THE PHYSICIAN PRESCRIBED ORAL MEDROL DOSEPAK AND CIPRO FOR ONE WEEK AND THEN PRESCRIBED ORAL KEFLEX, AND IBUPROFIN. THE PHYSICIAN ALSO PRESCRIBED TOPICAL CORTISONE CREAM. THE PHYSICIAN STATED THAT THE PATIENT PROBABLY SCRATCHED THE TREATMENT SITE DUE TO THE ITCHING, WHICH MAY HAVE CONTRIBUTED TO THE SITE SCABBING AND POSSIBLY CONTRIBUTED TO THE AREA BEING RED AND PAINFUL. LMX TOPICAL ANESTHETIC CREAM WAS USED PRIOR TO TREATMENT. IN ADDITION TO THE DERMAL FILLER TREATMENT, THE PATIENT HAD A FACIAL PEEL THE SAME DAY. THE PHYSICIAN THOUGHT THAT HAVING THE FACIAL PEEL TREATMENT AFTER THE DERMAL FILLER TREATMENT MIGHT HAVE CAUSED SYMPTOMS TO ONSET. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2007-00030. THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURED BY CORNEAL. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS JUVEDERM LMH CORNEAL NA HV30239631

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention FACIAL PEEL| ESTROGEN| CYMBALTA| LIPITOR| BOTOX