BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 2922349 · Received January 11, 2013

    Report

    Report Number
    3005113652-2013-00004
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REPORT SUMMARY: BATCH NUMBER (B)(4) WAS RELEASED BY QC ACCORDING TO DEFINED SPECIFICATIONS. THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL MANUFACTURING STEPS AND ALL PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE. DEVICE LABELING NOTES: UNDESIRABLE EFFECTS: MEDICAL PRACTITIONERS MUST INFORM THE PT THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING AND PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. THESE REACTIONS MY LAST FOR A WEEK. HAEMATOMAS, INDURATION OR NODULES AT THE INJECTION SITE. STAINING OR DISCOLOURATION OF THE INJECTION SITE. PTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK, OR ANY OTHER SIDE EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD USE AN APPROPRIATE TREATMENT.

    Description of Event or Problem · 1

    ALLERGAN REP RECEIVED A REPORT FROM A PHYSICIAN WHO NOTED AFTER INJECTION WITH ONE SYRINGE OF JUVEDERM ULTRA XC IN THE LIPS THE PT EXPERIENCED "INDURATION, PAIN, EDEMA, RASH AND BLEEDING." TREATMENT INCLUDED A COLD COMPRESS ALONG WITH CORTICOID AND VOLTARAN BUT SOME SYMPTOMS ARE STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18013 JUVEDERM ULTRA XC 1 ML ROW LMH ALLERGAN NA H24L905828

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention