BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 7027964 · Received November 14, 2017

    Report

    Report Number
    3005113652-2017-01408
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    July 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "MIGRATION", "SWOLLEN", "LUMPS", AND "? GRANULOMA", ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE LABELING ADDRESSES THE REPORTED EVENT(S) AS FOLLOWS: 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. INDURATION OR NODULES AT THE INJECTION SITE. RARE BUT SERIOUS ADVERSE EVENTS ASSOCIATED WITH INTRAVASCULAR INJECTION OF DERMAL FILLERS IN THE FACE AND TISSUE COMPRESSION HAVE BEEN REPORTED AND INCLUDE TEMPORARY OR PERMANENT VISION IMPAIRMENT, BLINDNESS, CEREBRAL ISCHEMIA OR CEREBRAL HEMORRHAGE, LEADING TO STROKE, SKIN NECROSIS AND DAMAGE TO UNDERLYING STRUCTURES. IMMEDIATELY STOP THE INJECTION IF A PATIENT EXHIBITS ANY OF THE FOLLOWING SYMPTOMS, INCLUDING CHANGES IN THE VISION, SIGNS OF STROKE, BLANCHING OF THE SKIN OR UNUSUAL PAIN DURING OR SHORTLY AFTER THE PROCEDURE. PATIENTS SHOULD RECEIVE PROMPT MEDICAL ATTENTION AND POSSIBLY EVALUATION BY AN APPROPRIATE MEDICAL PRACTITIONER SPECIALIST SHOULD AN INTRAVASCULAR INJECTION OCCUR. ABSCESSES, GRANULOMA AND IMMEDIATE OR DELAYED HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE ALSO BEEN REPORTED. IT IS THEREFORE ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED: PATIENT WAS INJECTED WITH JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE, "OVER 2 APPOINTMENTS". PATIENT "HAD DENTAL TREATMENT (SCALE + POLISH). LIPS UNCOMPLICATED BEFORE DENTAL TREATMENT." PATIENT'S "LIPS BECAME SWOLLEN (^?GRANULOMA)", "LUMPS AND A MIGRATION INTO THE TOP BORDER". "PRESCRIBED PREDNISOLONE BY G.P. STILL SWOLLEN, SO WE PRESCRIBED CLARITHROMYCIN", AND HYALASE. SYMPTOMS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2017-01407 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808827 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA60381

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R DENTAL TREATMENT (SCALE + POLISH)