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Catalog Number 94201JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Skin Discoloration (2074); Vertigo (2134)
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Event Date 03/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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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 of "abscess on the lip area¿, ¿micro abscess and skin rash on the skin, and hand-feet¿, ¿abscess under skin on clavicular¿, ¿color change¿, and ¿vertigo" 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: contra-indications: "do not inject juvéderm® volift¿ with lidocaine in the periorbital area (eyelids, under-eye area, crow¿s feet) and glabellar region." 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.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).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.Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.The medical practitioner should use an appropriate treatment.".
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Event Description
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Healthcare professional reported patient was injected in "glabella line, precoupe ulkus, and lip" with 1ml of juvéderm® volift¿ with lidocaine and in the cheek with 1 ml of unspecified juvederm® voluma¿.Three weeks later patient had touch up with unspecified dermal filler at all the same sites as initial injection.Ten days after injection abscess on the lip area is observed, 7 days later abscess drainage and cipro 500 is used as treatment.Additionally, reported treatment of betaserc due to vertigo.On the "12th days", micro abscess and skin rash are observed on the skin, and hand-feet." after 19 days, abscess under skin on clavicular is observed, color change after injection to glabella line is observed.Hyaluronidase is treated.Local treatment is started with nitroglycerin with cortisol and topical antibiotic pomade.Healing is observed on glabella line.Betaserc, leviation and cipro is prescribed as treatment.This is the same event and the same patient reported under mdr id# 3005113652-2017-00262 ((b)(4)) and mdr id# 3005113652-2017-00256 ((b)(4)).This is the first mdr submitted for the first suspect product, juvéderm® volift¿ with lidocaine.
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Event Description
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Additional information: prior to injection patient was pretreated with a topical antiseptic and after injection patient used ice.
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Manufacturer Narrative
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(b)(4).Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.
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Event Description
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Healthcare professional reported patient was injected in "glabella line, precoupe ulkus, and lip" with 1 ml of juvéderm® volift¿ with lidocaine and in the cheek with 1 ml of unspecified juvederm® voluma¿.Three weeks later patient had touch up with unspecified dermal filler at all the same sites as initial injection.Ten days after injection abscess on the lip area is observed, 7 days later abscess drainage and cipro 500 is used as treatment.Additionally, reported treatment of betaserc due to vertigo.On the "12th days", micro abscess and skin rash are observed on the skin, and hand-feet." after 19 days, abscess under skin on clavicular is observed, color change after injection to glabella line is observed.Hyaluronidase is treated.Local treatment is started with nitroglycerin with cortisol and topical antibiotic pomade.Healing is observed on glabella line.Betaserc, levation and cipro is prescribed as treatment.This is the same event and the same patient reported under mdr id# 3005113652-2017-00262 ((b)(4)) and mdr id# 3005113652-2017-00256 ((b)(4)).This is the first mdr submitted for the first suspect product, juvéderm® volift¿ with lidocaine.Additional information: prior to injection patient was pretreated with a topical antiseptic and after injection patient used ice.
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Search Alerts/Recalls
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