BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 7300782 · Received February 27, 2018

    Report

    Report Number
    3005113652-2018-00239
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 11, 2018
    Report Date
    May 25, 2018
    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 · 0

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT CONTACTED CLINIC STATING "FILLER HAS GONE". HCP WENT ON TO STATE THAT THE PATIENT'S CONDITION CAN'T BE EVALUATED UNLESS THE PATIENT RETURNS FOR REVIEW. HCP INDICATED "THE LUMPS WERE INITIALLY VERY STUBBORN". PATIENT "SAID [THEY] WANTS TO HAVE A BREAK FROM ANY FILLER AND WILL NOT [RETURN TO CLINIC] FOR CORRECTION." SYMPTOMS ARE ONGOING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS.: LMX 4%. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "LUMPY", "HARD", AND "SWOLLEN" 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: 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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL LATER REPORTED: "THE SYMPTOMS HAVEN¿T FULLY RESOLVED AS FIRM LUMPS ARE STILL PALPABLE BUT DO FEEL SMALLER IN SIZE TO THE [PATIENT]."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTED PATIENT WAS INJECTED ON WITH 1 ML JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE TO TT1, TT2, AND TT3, 1 ML UNSPECIFIED JUVÉDERM® VOLIFT¿ TO LIP AND SIDE OF MOUTH, 1 ML UNSPECIFIED JUVÉDERM® VOLUMA¿ TO JUST UNDER ZYGOMATIC BONE. LMX 4% CREAM WAS USED TO LIPS AS ANAESTHESIA, SKIN WAS THOROUGHLY CLEANSED WITH CHLORHEXIDINE PRIOR INJECTION, A STERILE DRESSING PACK WAS USED AND STERILE GLOVES WORN THROUGHOUT ADMINISTRATION OF FILLER. "NO MAJOR BRUISING OR SWELLING EVIDENT POST PROCEDURE." PATIENT WAS INJECTED WITH 14U OF BOTOX ON 2 MONTHS LATER TO GLABELLA AND AROUND EACH ORBICULARIS OCCULI. "[PATIENT'S] LIPS TEAR TROUGH AND CHEEKS HAD ALL SEEMED TO OF SETTLED WELL AND NO PROBLEMS WERE VISIBLE AT THIS DATE." PATIENT WAS REVIEWED IN CLINIC 1 MONTH AFTER BOTOX INJECTION. ON EXAMINATION: "LIPS APPEARED TO BE EXTREMELY SWOLLEN AND LUMPY, [PATIENT] EXPRESSED [THEY] HAD NOT BEEN WELL WITH BAD COLD/FLU LIKE SYMPTOMS [SINCE] 8 WEEKS AND 1 DAY POST VYCROSS ADMINISTRATION)." "[PATIENT] SENT AWAY TO SEE IF ANY IMPROVEMENT WHEN RECOVERED FROM FLU AND PLANNED TO KEEP IN CONTACT OVER LIP SWELLING." HCP NOTED: "WE WERE QUERYING AT THIS POINT AS TO WETHER THE ILLNESS HAD FLARED UP THE VYCROSS PRODUCTS CAUSING DELAYED ADVERSE REACTION." TWO (2) WEEKS AFTER ONSET, PATIENT RETURNED TO CLINIC FOR EXAMINATION. PATIENT'S "LIPS WERE REALLY HARD AND HOW I CAN ONLY DESCRIBE AS LIKE THEY HAD BEEN INJECTED WITH CEMENT, THERE WERE VISIBLE AND PALPABLE LUMPS WHICH FELT SHARP AND FORMED INTO SEGMENTS OF THE LOWER LIP. [PATIENT] EXPRESSED NO MAJOR PAIN OR DISCOMFORT WHEN TOUCHING AND MASSAGING THE LIP." "EYES LOOK A LOT MORE SETTLED AND WERE NOT TO FIRM TO TOUCH SOME MINOR SWELLING TO LOWER/OUT EDGE OF ORBICULARIS OCCULI". PATIENT TREATED WITH "IBUPROFEN 400 MG TDS, CHLORPHENIRAMINE 4 MG EVERY 4-6 HOURS AND PREDNISOLONE 30 MG OD FOR LAST 7 DAYS". PATIENT RECEIVED HYLARONIDASE 89 UNITS IN LOWER LIP. HEALTHCARE PROFESSIONAL OBSERVED: "NOT MUCH CHANGE WAS FELT POST ADMINISTRATION AND THOROUGH MASSAGE THOUGH CLIENT STATED SHE COULD FEEL SOME RELIEF AND LIPS DID NOT FEEL AS TIGHT." PATIENT WAS PRESCRIBED AN ADDITIONAL 30 MG PREDNISOLONE FOLLOWING HYALURONIDASE. TWO (2) HOURS POST HYALURONIDASE, PATIENT INDICATED "LIPS FELT SOFTER. THE TENSION IN HER FACE FELT LIKE IT HAD RELIEVED AND OVERALL FELT MORE COMFORTABLE." TWO (2) DAYS LATER, PATIENT COMPLAINED OF MORE SWELLING IN LIPS AND EYES. UPON EXAMINATION, THE HEALTHCARE PROFESSIONAL NOTED "THE LUMPS WERE STILL HARD AND FIRM TO TOUCH THOUGH LIPS WERE SLIGHTLY MORE PALPABLE WITH SPACE BETWEEN THE LUMPS NO PRESENT. EYES WERE NOT SWOLLEN AT THIS POINT". A FURTHER 105U OF HYALURONIDASE WAS INJECTED TO LOWER LIPS. " THIS TIME I COULD FEEL A SLIGHT SIZE CHANGE WITHIN THE LUMPS AFTER A THOROUGH MASSAGE AND LIPS VISIBLY HAD A SMOOTHER EDGE AND THE WHITE OF THE LUMPS WAS NOT AS VISIBLE." SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2018-00240 ((B)(4)), AND MDR ID# 3005113652-2018-00241 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142060 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CHLORHEXIDINE, JUVÉDERM® VOLUMA¿, JUVÉDERM® VOLIFT| CHLORHEXIDINE, JUVÉDERM® VOLUMA¿, JUVÉDERM® VOLIFT