BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 6398705 · Received March 13, 2017

    Report

    Report Number
    3005113652-2017-00082
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    December 9, 2016
    Report Date
    March 28, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (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 DENTAL ABSCESS DRAINING INTO RIGHT CHEEK CAUSING CELLULITIS, INJECTION SITES BECAME HARD, INDURATED, SWOLLEN, AND GRANULOMATOUS WITH FACIAL DISFIGUREMENT, EXTREME SWELLING, CHANGE IN SENSATION AND PINS AND NEEDLES, AND FILLERS ACTED AS FOREIGN BODIES ATTACKED BY THE INFLAMMATORY PROCESSES 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: PRECAUTIONS FOR USE: ¿ "AS A MATTER OF GENERAL PRINCIPLE, IMPLANTATION OF MEDICAL DEVICE IS ASSOCIATED WITH A RISK OF INFECTION." 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. ¿ POOR EFFICIENCY OR POOR FILLING/RESTORATION EFFECT. ¿ 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."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THIS ISSUE: ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE EXTRUSION FORCE VALUE SHOWS AN EXPECTED CONSISTENCY OF THE PRODUCT. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    PATIENT, WHO IS ALSO AN ORTHODONTIST, REPORTED INJECTING THEIRSELF WITH 1ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE IN THE LIPS AND 1ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE IN THE CHEEKS. APPROXIMATELY EIGHT MONTHS LATER PATIENT DEVELOPED A "DENTAL ABSCESS UR DRAINING INTO RIGHT CHEEK CAUSING CELLULITIS." AFTER THIS "ALL INJECTION SITES PREVIOUSLY DONE BECAME HARD, INDURATED, SWOLLEN AND GRANULOMATOUS WITH FACIAL DISFIGUREMENT." PATIENT ALSO HAD EXTREME SWELLING, CHANGE IN SENSATION AND PINS AND NEEDLES IN THE INJECTED AREAS IN THE LIPS AND CHEEKS. THE FILLERS WERE NOTED TO HAVE "ACTED AS FOREIGN BODIES ATTACKED BY THE INFLAMMATORY PROCESSES." PATIENT CONSULTED A PLASTIC SURGEON WHO PRESCRIBED 5 WEEKS OF ANTIBIOTICS AND ANTI-INFLAMMATORIES, INCLUDING MEGAPEN, MOXIBAY, CIPROBAY, AUGMENTIN, CELESTAMINE, CATAFLAN, FLAGYL, PULMISON, AND MYPRODOL. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2017-00083 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT CLARIFIED THAT THEY ONLY INJECTED THEMSELVES WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. PATIENT WAS INJECTED BY ANOTHER PHYSICIAN 3 MONTHS LATER WITH JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181588 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A50051

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE