BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 6212187 · Received December 29, 2016

    Report

    Report Number
    3005113652-2016-00995
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 25, 2016
    Report Date
    February 3, 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

    CONCOMITANT THERAPIES: ALCOHOL INJECTION SWAB, ICE PACK, TAMOXIFEN, CALCICHEW, VITAMIN D, CO-TRIMOXAZOLE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF HARD LUMPS IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: 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: ¿ INDURATIONS OR NODULES AT THE INJECTION AREA."

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE RELEASE STEP COMBINED WITH THE ABSENCE OF ANY DEVIATION SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND 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

    HEALTHCARE PROFESSIONAL REPORTED PRIOR TO INJECTION PATIENT WAS PRETREATED WITH LMX, CHLORHEXIDINE, ALCOHOL INJECTION SWAB, AND ICE PACK AND THEN INJECTED TO THE CHEEKS (CK5) AND LIPS (INCLUDING LP3 TOP LIP AND LP3 BOTTOM CENTER LIP) WITH JUVÉDERM® VOLIFT® RETOUCH AND TO THE CHEEKBONES (CK4) WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. PATIENT USED ICE AND CHLORHEXIDINE AFTER INJECTION. FOUR MONTHS LATER PATIENT DEVELOPED "HARD VISIBLE LUMPS IN LIPS (LIKE INSECT BITES), PALPABLE BUT NOT VISIBLE LUMPS IN CHEEKS WHERE PRODUCTS HAVE BEEN PLACED." PATIENT WAS ADVISED TO TAKE ORAL ANTIHISTAMINES, ORAL ARNICA, APPLY TOPICAL 1% HYDROCORTISONE TO LIPS FOR 1 WEEK, AND TO GENTLY MASSAGE LIPS. THE REPORTING PHYSICIAN NOTES "THE LUMPS TO THE LIPS ARE STARTING TO REDUCE, UNFORTUNATELY THE LUMPS TO THE CHEEKS ARE GETTING WORSE." PATIENT WAS TAKING TAMOXIFEN, CALCICHEW, VITAMIN D, AND "CO-TRIMOXAZOLE FOR A SEPARATE ISSUE" AT THE TIME OF INJECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT STILL HAS "HARD LUMPS" WHICH WERE DESCRIBED AS "FEELING AS HARD AS MARBLES." THE LUMPS HAVE "BROKEN UP INTO SMALLER LUMPS" BUT THE VOLUME OF THE LUMPS REMAIN THE SAME. PATIENT HAS BEEN MASSAGING THE AREA USING THE "BACK OF AN ELECTRIC TOOTHBRUSH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862977 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A60165

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention JUVÉDERM® VOLIFT® RETOUCH, LMX, CHLORHEXIDINE