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Catalog Number 94640 |
Device Problems
Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Local Reaction (2035)
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Event Type
Injury
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Manufacturer Narrative
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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.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 ¿reacting¿ and ¿abscess¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: contraindications: ¿ juvéderm voluma® xc is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.¿ juvéderm voluma® xc contains trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of allergies to such material.¿ juvéderm voluma® xc contains lidocaine and is contraindicated for patients with a history of allergies to such material.Precautions: ¿ health care professionals are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.Warnings: ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks.Refer to the adverse events section for details.Adverse events: ¿the following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.
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Event Description
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Company representative reported that a patient was "reacting" 10 days post injection with juvéderm voluma® xc.It was noted that it looked like a reaction at first and then developed into abscess eventually.Treatment was noted as doxycycline, ¿prednisone doxy, ¿prednisone taper¿, ¿hyaluronidase¿, ¿septra/[illegible], ¿fail aspiration¿, ¿labs 11/22 more hylanex 3 cc [illegible] cheek to cx, [illegible], added clinda¿, ¿admitted to shme cx sent, r cheek puss aspirated, l cheek, ct max, drainable fluid zoysn +vanco wbc 17.6 cx- ngtd, clinically got worse in hospital- id [illegible]¿, ¿surgical ied in operating room (or), 4 vials of tylenol used too¿, ¿i and d/hyaluronidase.¿ total of 6 vials of hyaluronidase used.Event is ongoing at this time.Event lead to "lid retraction.".
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Manufacturer Narrative
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Additional information: evaluation codes.
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Event Description
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Company representative reported that a patient was "reacting" 10 days post injection with juvéderm voluma® xc.It was noted that it looked like a reaction at first and then developed into abscess eventually.It was also noted that there was a possibility of "product being contaminated." treatment was noted as doxycycline, ¿prednisone doxy, ¿prednisone taper¿, ¿hyaluronidase¿, ¿septra/[illegible], ¿fail aspiration¿, ¿labs 11/22 more hylanex 3cc [illegible] cheek to cx, [illegible], added clinda¿, ¿admitted to shme cx sent, r cheek puss aspirated, l cheek, ct max, drainable fluid zoysn +vanco wbc 17.6 cx- ngtd, clinically got worse in hospital- id [illegible]¿, ¿surgical ied in or, 4 vials of tylenol used too¿, ¿i&d/hyaluronidase.¿ total of 6 vials of hyaluronidase used.Event is ongoing at this time.Event lead to "lid retraction.".
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Search Alerts/Recalls
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