BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 5895382 · Received August 22, 2016

    Report

    Report Number
    3005113652-2016-00651
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 3, 2016
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SWELLING AND HARD NODULES 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 OF SWELLING AND HARD NODULES 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: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.), WHICH CAN OCCUR SIMULTANEOUSLY WITH ITCHING OR PAIN ON PRESSURE, CAN APPEAR AFTER THE INJECTION. THESE REACTIONS CAN LAST FOR A WEEK. INDURATIONS OR NODULES AT THE INJECTION AREA."

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE 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 STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED TO THE CHIN AND CHEEKS (INCLUDING CK1, CK2, CK3, AND CK5) WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. NINE DAYS LATER, PATIENT WAS INJECTED TO THE LIP AND PERIORAL AREA WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. SIX MONTHS LATER, PATIENT WAS INJECTED TO THE CHEEKS WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AS WELL AS CONCOMITANT INJECTION TO THE ¿NA + NLF + PHILTRUM + LIPS¿ WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. PRIOR TO THIS INJECTION, PATIENT WAS PRETREATED WITH LMX-4. A MONTH LATER, PATIENT RETURNED TO THE INJECTING PHYSICIAN WITH SWELLING IN THE NASAL ALA AREA AND LIPS AND MULTIPLE HARD NODULES ON CHEEKS, CK2-LEFT, CHIN, C2 AND C4, ALONG NLF, AROUND LIPS, AND IN NA AREAS. PATIENT WAS PRESCRIBED CLARITHROMYCIN, CLINDAMYCIN, TETRACYCLINE, AND WAS INJECTED WITH HYALURONIDASE TWICE. SYMPTOMS ARE ONGOING. PATIENT WAS TAKING AMLODIPINE AT THE TIME OF INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2016-00652 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, THE FIRST INJECTION OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED TO THE CHIN AND CHEEKS (INCLUDING CK1, CK2, CK3, AND CK5) WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. NINE DAYS LATER PATIENT WAS INJECTED TO THE LIP AND PERIORAL AREA WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. SIX MONTHS LATER PATIENT WAS INJECTED TO THE CHEEKS WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AS WELL AS CONCOMITANT INJECTION TO THE ¿NA + NLF + PHILTRUM + LIPS¿ WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. PRIOR TO THIS INJECTION PATIENT WAS PRETREATED WITH LMX-4. A MONTH LATER PATIENT RETURNED TO THE INJECTING PHYSICIAN WITH SWELLING IN THE NASAL ALA AREA AND LIPS AND MULTIPLE HARD NODULES ON CHEEKS, CK2-LEFT, CHIN, C2 AND C4, ALONG NLF, AROUND LIPS, AND IN NA AREAS. PATIENT WAS PRESCRIBED CLARITHROMYCIN, CLINDAMYCIN, TETRACYCLINE, AND WAS INJECTED WITH HYALURONIDASE TWICE. SYMPTOMS ARE ONGOING. PATIENT WAS TAKING AMLODIPINE AT THE TIME OF INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2016-00652 (ALLERGAN COMPLAINT # (B)(4) ). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, THE FIRST INJECTION OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546734 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A50351

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention