BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 6152356 · Received December 7, 2016

    Report

    Report Number
    3005113652-2016-00957
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    September 10, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT THERAPIES: JUVÉDERM VOLIFT WITH LIDOCAINE. (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 NODULES, TENDERNESS, UNWELL WITH VIRUS COLD AND SPUTUM, HEADACHE, SWELLING, INCREASE IN FACIAL SIZE, DELAYED INFLAMMATORY TENDER SWOLLEN NODULES 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 AS FOLLOWS: UNDESIRABLE EFFECTS: "THE PATIENTS MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS DEVICE, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE (NON-EXHAUSTIVE LIST): INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ...) WHICH MAY BE ASSOCIATED WITH ITCHING, PAIN ON PRESSURE, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. IN PARTICULAR IT HAS TO BE NOTICED THAT INJECTION IN THE MUCOUS MEMBRANE MAY CAUSE MORE OEDEMA AND BRUISING DUE TO THE SPECIFIC PHYSIOLOGY OF THESE TISSUES. BESIDES, A PREVENTATIVE ANTI-INFLAMMATORY TREATMENT BY A MEDICAL PRACTITIONER CAN BE RECOMMENDED. INDURATIONS OR NODULES AT THE INJECTION SITE."

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE RELEASE STEP COMBINED WITH THE ABSENCE OF ANY DEVIATION SHOWS THAT 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 PATIENT WAS INJECTED TO THE CHEEKS AND CHIN (CK1, CK2, CK4, C1 AND C2) WITH JUVÉDERM VOLUMA WITH LIDOCAINE AND TO THE TAIL BROW, GLABELLA, AND FRONTALIS WITH BOTOX. A MONTH LATER PATIENT WAS INJECTED TO RIGHT CK1, RIGHT CK2, AND RIGHT CK3 WITH JUVÉDERM VOLUMA WITH LIDOCAINE AND TO THE LIPS AND C1 WITH JUVÉDERM VOLIFT WITH LIDOCAINE. A MONTH LATER PATIENT WAS INJECTED TO THE TEAR TROUGH AND LIPS WITH JUVÉDERM VOLBELLA WITH LIDOCAINE AND TO THE LOWER CHEEK/SMILE LINES/MASSETER REGION WITH JUVÉDERM VOLIFT WITH LIDOCAINE. PRIOR TO THE INJECTIONS PATIENT WAS PRETREATED WITH LMX. A MONTH AFTER THE LAST INJECTION PATIENT DEVELOPED 2 SMALL NODULES, 1 AT THE LEFT MASSETER AND 1 AT THE RIGHT MASSETER WITH NO PAIN OR REDNESS. TWO MONTHS LATER PATIENT REPORTS THE MASSETER IS NOW TENDER. PATIENT HAD BEEN ¿UNWELL FOR OVER A WEEK WITH VIRUS COLD AND SPUTUM.¿ PATIENT WAS ADVISED TO RETURN FOR REVIEW WHEN ¿COLD SETTLED OR EARLIER IF ANY DECLINE WITH NODULES IE REDNESS, DECLINE IN TENDERNESS OR HEAT TO TOUCH.¿ TWO DAYS LATER PATIENT FEELS THE NODULES AND DISCOMFORT ARE WORSE AND TWO DAYS AFTER THAT PATIENT RETURNED FOR REVIEW WITH ¿HEADACHE, MODERATE VISUAL FACIAL SWELLING, FACIAL TENDERNESS¿ AND INCREASE IN FACIAL SIZE. UPON EXAMINATION IT WAS NOTED PATIENT HAS ¿DELAYED INFLAMMATORY TENDER SWOLLEN NODULES TO MASSETER AND TEAR TROUGH.¿ PATIENT¿S TEMPERATURE FROM THE AXILLA WAS 36C. PATIENT WAS PRESCRIBED DOXYCYCLINE. AFTER 2 DAYS PATIENT HAS SOME SLIGHT IMPROVEMENT IN TEAR TROUGH SWELLING TO LEFT EYE BUT THE HEADACHE PERSISTS. PATIENT WAS TAKING ACYCLOVIR FOR SORE EYES AND PREDNISONE FOR ECZEMA AT THE TIME OF INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2016-00958 ((B)(4)) AND MDR ID #3005113652-2016-00959 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM VOLBELLA WITH LIDOCAINE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED TO THE CHEEKS AND CHIN (CK1, CK2, CK4, C1 AND C2) WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND TO THE TAIL BROW, GLABELLA, AND FRONTALLIS WITH BOTOX®. A MONTH LATER PATIENT WAS INJECTED TO RIGHT CK1, RIGHT CK2, AND RIGHT CK3 WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND TO THE LIPS AND C1 WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. A MONTH LATER PATIENT WAS INJECTED TO THE TEAR TROUGH AND LIPS WITH JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE AND TO THE LOWER CHEEK/SMILE LINES/MASSETER REGION WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. PRIOR TO THE INJECTIONS PATIENT WAS PRETREATED WITH LMX. A MONTH AFTER THE LAST INJECTION PATIENT DEVELOPED 2 SMALL NODULES, 1 AT THE LEFT MASSETER AND 1 AT THE RIGHT MASSETER WITH NO PAIN OR REDNESS. TWO MONTHS LATER PATIENT REPORTS THE MASSETER IS NOW TENDER. PATIENT HAD BEEN ¿UNWELL FOR OVER A WEEK WITH VIRUS COLD AND SPUTUM.¿ PATIENT WAS ADVISED TO RETURN FOR REVIEW WHEN ¿COLD SETTLED OR EARLIER IF ANY DECLINE WITH NODULES IE REDNESS, DECLINE IN TENDERNESS OR HEAT TO TOUCH.¿ TWO DAYS LATER PATIENT FEELS THE NODULES AND DISCOMFORT ARE WORSE AND TWO DAYS AFTER THAT PATIENT RETURNED FOR REVIEW WITH ¿HEADACHE, MODERATE VISUAL FACIAL SWELLING, FACIAL TENDERNESS¿ AND INCREASE IN FACIAL SIZE. UPON EXAMINATION IT WAS NOTED PATIENT HAS ¿DELAYED INFLAMMATORY TENDER SWOLLEN NODULES TO MASSETER AND TEAR TROUGH.¿ PATIENT¿S TEMPERATURE FROM THE AXILLA WAS 36C. PATIENT WAS PRESCRIBED DOXYCYCLINE. AFTER 2 DAYS PATIENT HAS SOME SLIGHT IMPROVEMENT IN TEAR TROUGH SWELLING TO LEFT EYE BUT THE HEADACHE PERSISTS. PATIENT WAS TAKING ACYCLOVIR FOR SORE EYES AND PREDNISONE FOR ECZEMA AT THE TIME OF INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2016-00958 ((B)(4)) AND MDR ID #3005113652-2016-00959 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803943 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA50395

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention ACICLOVIR, PREDNISONE, PRETREATMENT: LMX