BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 7069441 · Received November 29, 2017

    Report

    Report Number
    3005113652-2017-01532
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 7, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM.

    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 INFLAMED, FIRM, TENDER, PRESSURE, SINUS HEADACHE, SWELLING AND INFECTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING FOR THE REPORTED EVENTS OF INFLAMMATION, INFECTION, HEADACHE, PAIN, EDEMA AND SKIN IRRITATION: PRECAUTIONS FOR USE. AS A MATTER OF GENERAL PRINCIPLE, INJECTION OF A MEDICAL DEVICE IS ASSOCIATED WITH A RISK OF INFECTION. STANDARD PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED. UNDESIRABLE EFFECTS: THE PATIENTS 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 MAY BE ASSOCIATED WITH ITCHING AND/OR PAIN ON PRESSURE AND/OR PARAESTHESIA, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. INDURATION OR NODULES AT THE INJECTION SITE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: SYMPTOMS RESOLVED ON (B)(6) 2017 AFTER 8 TREATMENTS WITH HYLASE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLUMA® WITH LIDOCAINE IN THE CHEEKS (CK1, CK2, CK3), ALAR BASE AND NASOLABIAL FOLDS. PRIOR TO TREATMENT, THE PATIENT UNDERWENT THOROUGH CLEANING OF SKIN AND CLEAN ASEPTIC TECHNIQUE. A WEEK LATER, THE PATIENT WAS REVIEWED AND THE PRODUCT WAS STILL INTEGRATING. PATIENT WAS VERY HAPPY WITH RESULT. ON THE FOLLOWING MONTH, THE PATIENT HAD A DENTAL IMPLANT TO THE RIGHT LOWER TOOTH. ABOUT A WEEK LATER, THE PATIENT HAD THE LEFT UPPER TOOTH DRILLED WITH INITIAL INTENSE PAIN TO THE SITE. PATIENT HAD BEEN GIVEN A "GEL" TO SUBSIDE PAIN WITH SUCCESS. NO ANTIBIOTICS PROPHYLAXIS WAS GIVEN IN EITHER PROCEDURE. TWO WEEKS LATER, THE FILLER BECAME INFLAMED. THREE DAYS LATER, THE PATIENT CALLED THE CLINIC CONCERNED WITH THE "FILLER INFLAMED." PATIENT WAS REVIEWED AND FILLER WAS "FIRM IN BILAT[ERAL] ALAR BASES" AND MORE FIRM ON THE LEFT SIDE. THE AREA WAS TENDER ON PALPATION AND SLIGHTLY INFLAMED. IT WAS NOTED THAT THE FILLER WAS CAUSING "PRESSURE" WITH SLIGHT SINUS HEADACHE. PATIENT WAS PRESCRIBED KEFLEX BY A PHYSICIAN. FOUR DAYS LATER, THE PATIENT CALLED THE CLINIC NOTING THAT THE SWELLING TO FILLER PROGRESSIVELY GETTING WORSE AND HAS BEEN TAKING KEFLEX AS PRESCRIBED. PATIENT HAD GONE TO THEIR GENERAL PRACTITIONER AND WAS PRESCRIBED AUGMENTIN FORTE. PATIENT WAS REVIEWED AND THE FILLER IN THE NASOLABIAL FOLD WAS SLIGHTLY MORE INFLAMED AND FIRMER THAN IT WAS ON THE PREVIOUS REVIEW. THE FILLER ON THE CK1 AND CK2 IS NOW SLIGHTLY INFLAMED WHICH WAS NOT BEFORE ON PREVIOUS REVIEW. PATIENT WAS TREATED WITH HYLASE AFTER CONSULTING WITH THE PHYSICIAN AND MASSAGED AFTER THE TREATMENT. PATIENT WAS THEN GIVEN A YELLOW LED AFTER THE TREATMENT. PATIENT ADDITIONALLY ADVISED TO TAKE ANTIHISTAMINES. ON THE FOLLOWING DAY, THE PATIENT'S FACE WAS "FURTHER SIGNIFICANTLY INFLAMED" AND WAS ADVISED TO ATTEND A HOSPITAL FOR FURTHER ASSESSMENT/TREATMENT. THE EVENT WAS NOTED AS AN INFECTION. THE HOSPITAL WAS NOT CONCERNED THAT THE PATIENT HAD FURTHER INFECTION AND NO TREATMENT WAS DONE. PATIENT WAS AGAIN REVIEWED BY THE PHYSICIAN THE FOLLOWING DAY AND WAS TREATED WITH CIPROFLOXACIN TO REDUCE INFLAMMATION. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846655 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A70191

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention