Further information from the reporter regarding event details has been requested.No additional information is available at this time.The events of "nodules", "red papule", "pustule", and "abscess" 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.
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Healthcare professional reported patient was injected with.6ml of juvéderm® volbella¿ with lidocaine in the periorbital and gabella regions, and 1ml of juvéderm® ultra 3 in the nasolabial folds and marionette lines.Eleven days post injection "nodules developed".Healthcare professional later reported patient had "[illegible] red papule, pustule, abscess." patient was treated with clarithromycin 2 x 500mg and rifampicin 2 x 300mg for four weeks.Also ciprofloxacin 2 x 500mg.Patient received octenisept pre-injection, and fucidin acid local post-injection.Symptoms ongoing.
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