BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 6052205 · Received October 24, 2016

    Report

    Report Number
    3005113652-2016-00865
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    May 10, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT THERAPIES: JUVÉDERM VOLBELLA WITH LIDOCAINE; PRETREATMENT: HIBIDIL AND LIDOCAINE; POST TREATMENT: GEL ICE PACKS FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF NODULAR SWELLING IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF NODULAR SWELLING AS FOLLOWS: UNDESIRABLE EFFECTS "THE PATIENT MUST BE INFORMED 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 CAN OCCUR SIMULTANEOUSLY WITH ITCHING OR PAIN ON PRESSURE, CAN APPEAR AFTER THE INJECTION. THESE REACTIONS CAN LAST FOR A WEEK. INDURATIONS OR NODULES AT THE INJECTION AREA."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED TO THE CHEEKS AND TEMPORAL WITH 2.5ML OF JUVÉDERM® VOLUMA" WITH LIDOCAINE, TO THE MOUTH CORNER, LABIOMENTAL, CHEEKS, NASOLABIAL, MARIONETTE, BROW, KEN, [ILLEGIBLE], GMG, AND MASSETER WITH 6ML OF JUVÉDERM® VOLIFT" WITH LIDOCAINE, AND TO THE LIPS WITH 0.8ML OF JUVÉDERM® VOLBELLA" WITH LIDOCAINE. PATIENT WAS ALSO CONCOMITANTLY INJECTED WITH BOTOX®. PRIOR TO INJECTION PATIENT WAS PRETREATED WITH HIBIDIL AND LIDOCAINE AND AFTER INJECTION PATIENT USE GEL ICE PACKS. APPROXIMATELY 10 WEEKS LATER PATIENT DEVELOPED NODULAR SWELLING IN ALL TREATED AREAS. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (AVALON) AND ORAL STEROID (METICORTEN). SYMPTOMS RESOLVED 2 MONTHS LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2016-00866 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA" WITH LIDOCAINE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED TO THE CHEEKS AND TEMPORAL WITH 2.5ML OF JUVEDERM VOLUMA WITH LIDOCAINE, TO THE MOUTH CORNER, LABIOMENTAL, CHEEKS, NASOLABIAL, MARIONETTE, BROW, "KEN", [ILLEGIBLE], "GMG" AND MASSETER WITH 6ML OF JUVEDERM VOLIFT WITH LIDOCAINE, AND TO THE LIPS WITH 0.8ML OF JUVEDERM VOLBELLA WITH LIDOCAINE. PATIENT WAS ALSO CONCOMITANTLY INJECTED WITH BOTOX. PRIOR TO INJECTION PATIENT WAS PRETREATED WITH HIBIDIL AND LIDOCAINE AND AFTER INJECTION PATIENT USE GEL ICE PACKS. APPROXIMATELY 10 WEEKS LATER PATIENT DEVELOPED NODULAR SWELLING IN ALL TREATED AREAS. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (AVALON) AND ORAL STEROID (METICORTEN). SYMPTOMS RESOLVED 2 MONTHS LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2016-00866 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703981 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A50369

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention JUVÉDERM VOLIFT WITH LIDOCAINE, BOTOX