BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK ROW

    MDR report key: 2210345 · Received August 9, 2011

    Report

    Report Number
    3005113652-2011-00060
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2011. DEVICE EVALUATION SUMMARY: BATCH NUMBER H24L620627 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 PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE AND THE STERILITY TEST ARE REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT 15 DAYS AFTER INJECTION WITH JUVEDERM ULTRA XC IN MULTIPLE UNSPECIFIED AREAS, THE PATIENT EXPERIENCED CYSTS AND ABSCESSES AT THE INJECTION SITES. THE PATIENT WAS TREATED WITH CEFAMOX FOR 7 DAYS, CIPRO FOR 10 DAYS AND ANOTHER UNSPECIFIED MEDICATION. PER THE PHYSICIAN, TREATMENT WAS PRESCRIBED TO PREVENT WORSENING OF SYMPTOMS WHICH COULD HAVE LED TO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA XC TSK ROW LMH ALLERGAN NA H24L620627

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention