BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 6776575 · Received August 9, 2017

    Report

    Report Number
    3005113652-2017-00825
    Event Type
    Injury
    Date Received
    August 9, 2017
    Report Date
    August 9, 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

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "BIOFILM", "INFECTION", "HARD, SLIGHTLY PAINFUL LUMP", "SWELLING", "HEAT", AND "REDNESS" 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 EVENT(S) AS FOLLOWS: 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 SHALL 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 PARESTHESIA, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. INDURATION OR NODULES AT THE INJECTION SITE.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED: THE PATIENT WAS INJECTED WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE IN THE RIGHT CHEEK. THE NEEDLE PROVIDED IN THE BOX WAS USED ALONG WITH A 25G CANULAE "BLUNT TIP 38CM LONG". THE PATIENT PRESENTED WITH INFECTION ON RIGHT CHEEK A WEEK AFTER INJECTION. THE PATIENT WAS TREATED WITH "FLUCLOXICOLLIN 500MG QDS". "3 MONTHS POST-INJECTION, THE PATIENT PRESENTED WITH "BIOFILM", "LATE ONSET INFLAMMATORY REACTION", "REDNESS", " HARD SLIGHTLY PAINFUL LUMP IN CK4", "NODULE AT THE ALA AT THE TOP OF LEFT NASO LABIAL FOLD AND 2 SMALLER ALONG THE GOLD." THE PATIENT WAS TREATED WITH CLINDIMICYN 300MG AND CO-AMOXYCLAV 250, CLARITHROMYCIN, CIPROFLOXIN, FLUCLOXICOLLIN 500MG QDS, HYLASE; "HYALURONIDASE AND CIPROFLOXACIL"". SYMPTOMS ARE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557082 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A60505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention