BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VOLBELLA

    MDR report key: 6722648 · Received July 18, 2017

    Report

    Report Number
    3005113652-2017-00701
    Event Type
    Injury
    Date Received
    July 18, 2017
    Report Date
    July 18, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS WILL BE/HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF ¿SWELLING WITH BURNING SENSATION AND RED COLOR" AND "PRESUMED BIOFILM¿ 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, 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. 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 PREVENTIVE ANTI-INFLAMMATORY TREATMENT BY A MEDICAL PRACTITIONER CAN BE RECOMMENDED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN INJECTION OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE IN THE "DARK CIRCLES". AN UNSPECIFIED TIME LATER, AFTER A DENTAL TREATMENT, THE PATIENT PRESENTED WITH "SWELLING WITH BURNING SENSATION AND RED COLOR ON THE INJECTED AREA." IT IS ALSO NOTED, THE DOCTOR "PRESUMED BIOFILM". THE PATIENT WAS TREATED WITH ANTIBIOTICS AND CORTICOIDS AND AFTER DAY 14 THERE HAS BEEN NO IMPROVEMENT. SYMPTOMS ARE ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504091 UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention