(b)(4).Further information from the reporter regarding event details has been requested.No additional information is available at this time.The events of "vascular necrosis", "swelling", "peeling", "postules", "discolored skin", and "bruising" 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 initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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.Induration or nodules at the injection site.Staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect).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 (hcp) reported patient was injected with 1 ml of juvéderm® voluma¿ with lidocaine in the chin on 2 occasions a few weeks apart.Patient received lidocaine cream before injections.After the second injection, patient experienced swelling in the chin.The next day, patient presented with discolored skin, which they thought may have been bruising.Patient contacted hcp and sent a picture.Hcp observed signs of necrosis - later diagnosed as "vascular necrosis, secondary to compression".Hcp also observed "peeling to skin" and postules.Patient treated with "aspirin 300 mg, ciprofloxacin 500 mg bd, clarithromycin 500 mg bd, hyalase 1500 iu x3 vials", and warm compress.Patient "unable to tolerate clarithromycin (pins and needles) so adv to stop that and continue on ciprofloxacin." symptoms ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2018-00920 ((b)(4)).This is the first mdr submitted for the second injection of suspect product, juvéderm® voluma¿ with lidocaine.
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