(b)(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 swelling, redness, lump, and sebaceous cyst 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.Induration or nodules at the injection site.
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Healthcare professional reported patient was injected to the ck, jw, and m codes with unspecified products from juvéderm® vycross range on two previous occasions.An unspecified amount of time later patient was injected to the lips with juvéderm® volbella¿ with lidocaine.A few weeks later patient was reviewed and had a ¿small lump submalar¿ that was nowhere near where the filler is.Patient had recently had a sebaceous cyst and was advised to see their gp who prescribed penicillin.Patient had a terrible allergy to it with ¿swelling +++¿ and was swapped to clarithromycin and swelling was 50% improved.Patient was then reviewed by the injector who noted that some of the injection sites, including ck1 and ck2, have now swelled.Marionettes are red and inside there¿s massive swelling that is about half the size of a golf ball.Patient¿s lower lip had developed a large swollen lump.None are painful and they feel soft and are reducing.The injector advised that the allergic reaction to the penicillin may have triggered this flare up at some of the injection sites and patient really needs prednisolone.Patient was advised to return to their gp to be prescribed prednisolone.Symptoms are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2017-01058 (allergan complaint #(b)(4)) and mdr id# 3005113652-2017-01084 (allergan complaint #(b)(4)).This mdr is being submitted for second injection of unspecified juvéderm® vycross.
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