BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JEVEDERM ULTRA PLUS XC TSK US

    MDR report key: 2894188 · Received December 27, 2012

    Report

    Report Number
    3005113652-2012-00133
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY REPORT SUMMARY: BATCH NUMBER (B)(6) 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. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED RECEIVING A REPORT FROM A PHYSICIAN WHO NOTED THAT AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC PATIENT EXPERIENCED "SUPERFICIAL INFECTION" 48 HOURS AFTER INJECTION. MEDROL DOSEPAK AND KEFLEX WERE PRESCRIBED AND THE SYMPTOMS ARE IMPROVING. PATIENT HAD THE SAME REACTION TO A JUVEDERM INJECTION FOUR (4) YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JEVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30L880355

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention