BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 2202044 · Received August 5, 2011

    Report

    Report Number
    3005113652-2011-00059
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT SENT TO FDA ON (B)(4) 2011.

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL HAD SEEN A PATIENT IN THE CLINIC PRESENTING WITH AN "INFLAMMATORY GRANULOMA, VERY INFECTED." THE PATIENT HAD VISITED A DERMATOLOGIST PREVIOUSLY AND IS RECEIVING ANTIBIOTICS (UNSPECIFIED) TO HEAL THE INFECTION FROM THESE LESIONS. THE PATIENT REPORTED TREATMENT APPROXIMATELY ONE YEAR AGO AND HAS HAD SYMPTOMS FOR THE PAST SIX WEEKS. HOWEVER, THE PATIENT REPORTED EXPERIENCING 'LUMPINESS' WHEN FIRST INJECTED. THE PATIENT RECEIVED JUVEDERM ULTRA PLUS (DOSAGE UNKNOWN) IN THE NASOLABIAL FOLDS, ORAL COMMISSURES AND IN THE CHEEKS. NO KNOWN HISTORY OF ALLERGIES OR OTHER ILLNESSES. FOLLOW UP FINDINGS: THE PATIENT WAS PRESCRIBED 50 MG OF MINOCYCLINE TWICE DAILY. ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention