BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS TSK ROW

    MDR report key: 2926126 · Received January 16, 2013

    Report

    Report Number
    3005113652-2012-00141
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    July 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REPORT SUMMARY: BATCH NUMBER HV30772116 WAS RELEASED BY QC ACCORDING TO DEFINED SPECS. THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE. DEVICE LABELING: CONTRA-INDICATIONS: DO NOT INJECT INTO THE BLOOD VESSELS (INTRAVASCULAR).

    Description of Event or Problem · 1

    ALLERGAN REP REPORTED RECEIVING A REPORT FROM A PHYSICIAN WHO NOTED AFTER INJECTION WITH JUVEDERM ULTRA PLUS IN THE NOSE AREA THE PT PRESENTED AT THE CLINIC WITH "NECROSIS" ELEVEN (11) DAYS LATER. PT WAS TREATED WITH HYALASE, ANTIBIOTICS, DRESSING AND LASER TONING. PT'S SYMPTOMS HAVE RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT WAS INJECTED TO THE FOREHEAD, NOT TO THE NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23948 JUVEDERM ULTRA PLUS TSK ROW IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN NA HV30772116

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention