BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 5201748 · Received November 4, 2015

    Report

    Report Number
    3005113652-2015-00680
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 13, 2015
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 11/04/2015. (B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF PAIN, CENTRAL WHITISH AREA, REDNESS/ERYTHEMA, THROMBUS, AND ARTERITIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF PAIN, CENTRAL WHITISH AREA, REDNESS/ERYTHEMA, THROMBUS, AND ARTERITIS AS FOLLOWS: CONTRA-INDICATIONS " DO NOT INJECT INTO THE BLOOD VESSELS (INTRAVASCULAR)." UNDESIRABLE EFFECTS "THE PATIENT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS LINKED TO THIS PROCEDURE, WHICH CAN BE EITHER IMMEDIATE OR 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. STAINING OR DISCOLOURATION OF THE INJECTION SITE. PATIENTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE."

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DESCRIBE EVENT OR PROBLEM.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: 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 TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THE DAY AFTER INJECTION TO THE NASOLABIAL GROOVE WITH JUVEDERM ULTRA XC PATIENT DEVELOPED PAIN IN THE CORNER OF THE LEFT NASAL WING. ON THIS DAY PATIENT WAS EXAMINED BY INJECTING PHYSICIAN WHO NOTED "CENTRAL WHITISH AREA AND ERYTHEMATOUS ON THE LEFT NASAL CANTO CORNER AND ON THE LEFT NASAL WING (RIGHT IN THE PATH OF ANGULAR ARTERY) AND PATIENT WAS INJECTED WITH HYALURONIDASE. PATIENT WAS ALSO TREATED WITH HEAT COMPRESS AND A NITRO-GLYCERIN PATCH. LATER THAT DAY THE PATIENT UNDERWENT A "DOPPLER" EXAM BY AN ANGIOLOGIST WHO NOTED "FREE ARTERY WITHOUT OBSTRUCTION." THE PHYSICIAN WONDERED IF THE HYALURONIDASE INJECTION DISSOLVED THE "THROMBUS." THE PATIENT WAS PRESCRIBED PREDNISONE, ASPIRIN, CILOSTAZOL, CLAVULIN BD. SYMPTOMS DID NOT IMPROVE AND THE PHYSICIAN WANTED A NEW DOPPLER WITH A PHYSICIAN "WHO HAS MORE EXPERIENCE". THIS EXAM ALSO SHOWED A FREE ARTERY AND "OBSERVED AN IMPORTANT ARTERITIS AN ANGULAR BRANCH." THE PATIENT CONTINUED WITH THE PRESCRIBED MEDICATIONS AND WAS REVIEWED EVERY DAY FOR A WEEK WITH "PROGRESSIVE IMPROVEMENT OF REDNESS AND WHITISH CENTER POINT. ON THE THIRD DAY PATIENT WAS "BETTER" AND ON THE FIFTH DAY THEY WERE "ALMOST GOOD." PATIENT ADDITIONALLY CONSULTED WITH A ANGIOLOGIST TO RESOLVE THE ARTERITIS. SYMPTOMS HAVE RESOLVED.

    Description of Event or Problem · 1

    IT WAS FOUND THAT MDR ID #3005113652-2016-00545 ((B)(4)) IS A DUPLICATE FOR THE SAME EVENT, SAME PATIENT AND SAME SUSPECTED PRODUCT FOR THIS MDR.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THE DAY AFTER INJECTION TO THE NASOLABIAL GROOVE WITH JUVÉDERM ULTRA¿ XC PATIENT DEVELOPED PAIN IN THE CORNER OF THE LEFT NASAL WING. ON THIS DAY PATIENT WAS EXAMINED BY INJECTING PHYSICIAN WHO NOTED ¿CENTRAL WHITISH AREA AND ERYTHEMATOUS ON THE LEFT NASAL CANTO CORNER¿ AND ON THE LEFT NASAL WING (RIGHT IN THE PATH OF ANGULAR ARTERY) AND PATIENT WAS INJECTED WITH HYALURONIDASE. PATIENT WAS ALSO TREATED WITH HEAT COMPRESS AND A NITRO-GLYCERIN PATCH. LATER THAT DAY THE PATIENT UNDERWENT A ¿DOPPLER¿ EXAM BY AN ANGIOLOGIST WHO NOTED ¿FREE ARTERY WITHOUT OBSTRUCTION.¿ THE PHYSICIAN WONDERED IF THE HYALURONIDASE INJECTION DISSOLVED THE ¿THROMBUS.¿ THE PATIENT WAS PRESCRIBED PREDNISONE, ASPIRIN, CILOSTAZOL, CLAVULIN BD. SYMPTOMS DID NOT IMPROVE AND THE PHYSICIAN WANTED A NEW DOPPLER WITH A PHYSICIAN ¿WHO HAS MORE EXPERIENCE¿. THIS EXAM ALSO SHOWED A FREE ARTERY AND ¿OBSERVED AN IMPORTANT ARTERITIS AN ANGULAR BRANCH.¿ THE PATIENT CONTINUED WITH THE PRESCRIBED MEDICATIONS AND WAS REVIEWED EVERY DAY FOR A WEEK WITH ¿PROGRESSIVE IMPROVEMENT OF REDNESS AND WHITISH CENTER POINT. ON THE THIRD DAY PATIENT WAS ¿BETTER¿ AND ON THE FIFTH DAY THEY WERE ¿ALMOST GOOD.¿ PATIENT ADDITIONALLY CONSULTED WITH A ANGIOLOGIST TO RESOLVE THE ARTERITIS. SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731266 JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H24LA50055

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention