BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS TSK ROW

    MDR report key: 2926151 · Received January 16, 2013

    Report

    Report Number
    3005113652-2012-00139
    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
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(4) 2013. DEVICE HISTORY REPORT SUMMARY: BATCH NUMBER HV30772116 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 MFG STEPS AND ALL THE PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IOS 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 PATIENT PRESENTED AT THE CLINIC WITH ¿NECROSIS¿ ELEVEN (11) DAYS LATER. PATIENT WAS TREATED WITH HYALASE, ANTIBIOTICS, DRESSING AND LASER TONING. PATIENT¿S SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23651 JUVEDERM ULTRA PLUS TSK ROW LMH ALLERGAN NA HV30772116

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention