BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK ROW

    MDR report key: 2960546 · Received February 12, 2013

    Report

    Report Number
    3005113652-2013-00010
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(4) 2013. DEVICE HISTORY REPORT SUMMARY: BATCH NUMBER H30L676442 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, BIOBURBEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. 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). UNDESIRABLE EFFECTS. THE PATIENTS MUST BE INFORMED THAT THEY 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 OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. HAEMATOMAS. CASES OF NECROSES IN THE GLABELLAR REGION, ABSCESSES, GRANULOMA, AND IMMEDIATE OR DELAYED HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE BEEN REPORTED. IT IS THEREFORE, ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT. PATIENTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR DOCTOR AS SOON AS POSSIBLE. THE DOCTOR SHOULD USE AN APPROPRIATE TREATMENT. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF THE PRODUCT MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PHYSICIAN NOTED THAT AFTER INJECTION IN THE NOSE, BROWS AND CHIN WITH JUVEDERM ULTRA PLUS XC AND JUVEDERM VOLUMA XC PATIENT EXPERIENCED "SWELLING, PUFFINESS OF CHEEKS, AND EYE; LOSS OF VISION AFFECTED UP TO 70%, FILM ON EYE, PAIN AND HOT WHEN THERE'S EXERTING" NINE MONTHS AFTER INJECTION. PATIENT WAS HOSPITALIZED FOR A MONTH AND "VARIOUS TESTS WERE RAN, BUT NOTHING WAS FOUND." TREATMENT OF PREDNISOLONE FOR TWO WEEKS, SINGULAIR, AERIUS, TELFAST, PATANOL EYEDROPS, AND ENDURA EYEDROPS HAVE BEEN PROVIDED TO PATIENT BUT SYMPTOMS ARE STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60827 JUVEDERM ULTRA PLUS XC TSK ROW LMH ALLERGAN NA H30L676442

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization JUVERDERM VOLUMA XC