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(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.This is a known potential adverse event addressed in the product labeling.Device history record found no significant anomalies.No deviations or non-conformances were found.
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Healthcare professional reported injecting a patient with juvéderm volbella with lidocaine in the peri-orals.About 3 months later, the patient came back to the clinic with a nodule in the lower lip and swelling to their left lower face.The lip was uncomfortable to touch, no pain and a lump was felt on the inside the lower lip.Patient also had some flu symptoms that consisted of slight headache, sore throat and upset stomach.Patient was reviewed 6 days later.Patient was warm to touch and had lumps.Doctors were notified and it was recommended the patient be treated with antihistamine and paracetamol as needed.It was noted that it could be related to the patient feeling unwell/flu as their immune system is down.It was noted that in most cases it resolves on its own without further interventions.Patient had to stop taking antihistamines because of feeling dizzy.Two days later, the patient had no changes and was not feeling any better.Patient was then handed over to their prescribing doctor.Per the doctor, "four months down the track is stretching it as filler being the sudden cause of swelling." patient was then advised to go see their general practitioner to look for other signs of infection (lymph nodes etc).Patient was referred to a dermatologist after seeing their general practitioner.About 12 days later, the clinic manager spoke to another doctor.As per the doctor, "the case of [the patient] might be potential granuloma due to the time of the symptoms post initial treatment." patient was then advised to return for hyalase as the doctor had suggested that the product might have migrated.Patient noted that the flu symptoms have gone with the swelling and tenderness having reduced.Healthcare professional treated the patient with hyalase after the consultation with the doctor and the lumpiness settled immediately after.On the next day the patient complained about hard swelling that appeared to come back.The patient had also accidentally bitten on the hard lump inside their lip and noted that the lump was actually bigger than before with tenderness.After the patient saw a skin specialist, it was identified as either a disrupted salivary gland or a collection of blood vessels.Further diagnosis will be done after an ultrasound.Patient had complained about being injected with hyalase without identifying/confirming what the lumps were.After a discussion with the doctor, it was thought that the swelling was more likely to be resulted from the patient biting their lip which continuously irritates the area.Patient was suggested to give it time to go down and manage discomfort with anti-inflammatory medications.
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