ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE
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Catalog Number 94506KO |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971)
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Event Date 08/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Article citation: "delayed adverse events after using two different types of hyaluronic acid-based dermal fillers." han hye sung, yoo kwang ho, hong jun ki, kim beom joon, md, koh ik-soo, and hong soon auck; wiley dermatologic therapy, 09 august 2020.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Granuloma, "allergenic reaction", and "degenerating striated muscles" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.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.Clarification: granuloma and "allergenic reaction" are known potential adverse events addressed in the product labeling."degenerating striated muscles" is considered an unexpected adverse drug experience.
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Event Description
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Author, who is a healthcare professional, reported a delayed adverse event (dae) to juvéderm® voluma® with lidocaine and dermalax® implant plus via the ¿delayed adverse events after using two different types of hyaluronic acid-based dermal fillers¿ article.The patient was injected for midface volume deficits in the right cheek with 1.0 ml of juvéderm® voluma® with lidocaine, and in the left cheek with 1.0 ml of dermalax® implant plus.10 months after injection, the patient did not experience any complications; the cosmetic results were very satisfactory.13 months after injection, swelling and lumps began to develop; patient experienced swelling on both cheeks.1-month history of swelling in the right infraorbital area and left cheek.Patient did not have any recent history of a wound or infection.Ultrasonography revealed round hypoechoic lesions in the right infraorbital area (8.1 x 2.0 mm) and left cheek (26.3 x 4.6 mm).Gram staining and cultures performed with the aspirated material were negative.Methylprednisolone (4 mg/day) was started and intralesional hyaluronidase (1500 iu) with triamcinolone (10 mg/ml) injections; however, treatment results were unsatisfactory.Because patient wanted immediate resolution, incisional removal of nodules was planned.2 large masses were removed from the left cheek and perioral area, which underwent further histological evaluation; the specimen obtained from the right infraorbital area was negligible.Microscopically, granulomatous inflammation (also noted as foreign-body granuloma) with numerous eosinophils surrounding ha material was noted, and the lining epithelioid cells were cd68-positive and cytokeratin-negative, confirming their histiocytic nature.Degenerating striated muscles surrounded the pools of ha material.Two months after incisional removal, the swelling markedly improved.As part of the discussion the author noted that both fillers led to delayed adverse event.However, the juvéderm® voluma® with lidocaine reaction was stronger as per the ultrasound and amount of specimen obtained.The etiology of the event is debatable.Foreign-body type granulomas and eosinophilic infiltration were observed, suggesting an allergic reaction; furthermore, the degenerating striated muscles were noted, which is an uncommon feature in filler granulomas.This may be attributable to a chronic inflammatory or toxic response, leading to muscle degeneration or mass effects from surrounding edema.Additionally, the author reported that the product was used after the expiration date.The symptoms began about a year and a month after the injection date.The event ¿was an allergenic reaction to the product and it is related to the patient factors (immunological reaction) as well as the product.¿ 7 days after the date of onset, patient was started on methylprednisolone for 2 weeks.2 days later patient was injected with hyaluronidase with triamcinolone; a second injection was performed 5 days later.The incisional removal of nodules occurred 20 days later.The granuloma was removed through incision, but there are some scars left on the treatment area.Granuloma resolved 1 month and 4 weeks after the incision.Scar left on the treatment area is still under treatment.
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Manufacturer Narrative
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Additional data: b.1., b.2., section c., d.4., h.4., h.6.
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Event Description
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Author, who is a healthcare professional, reported a delayed adverse event (dae) to juvéderm® voluma® with lidocaine and dermalax® implant plus via the ¿delayed adverse events after using two different types of hyaluronic acid-based dermal fillers¿ article.The patient was injected for midface volume deficits in the right cheek with 1.0 ml of juvéderm® voluma® with lidocaine, and in the left cheek with 1.0 ml of dermalax® implant plus.10 months after injection, the patient did not experience any complications; the cosmetic results were very satisfactory.13 months after injection, swelling and lumps began to develop; patient experienced swelling on both cheeks.1-month history of swelling in the right infraorbital area and left cheek.Patient did not have any recent history of a wound or infection.Ultrasonography revealed round hypoechoic lesions in the right infraorbital area (8.1 x 2.0 mm) and left cheek (26.3 x 4.6 mm).Gram staining and cultures performed with the aspirated material were negative.Methylprednisolone (4 mg/day) was started and intralesional hyaluronidase (1500 iu) with triamcinolone (10 mg/ml) injections; however, treatment results were unsatisfactory.Because patient wanted immediate resolution, incisional removal of nodules was planned.2 large masses were removed from the left cheek and perioral area, which underwent further histological evaluation; the specimen obtained from the right infraorbital area was negligible.Microscopically, granulomatous inflammation (also noted as foreign-body granuloma) with numerous eosinophils surrounding ha material was noted, and the lining epithelioid cells were cd68-positive and cytokeratin-negative, confirming their histiocytic nature.Degenerating striated muscles surrounded the pools of ha material.Two months after incisional removal, the swelling markedly improved.As part of the discussion the author noted that both fillers led to delayed adverse event.However, the juvéderm® voluma® with lidocaine reaction was stronger as per the ultrasound and amount of specimen obtained.The etiology of the event is debatable.Foreign-body type granulomas and eosinophilic infiltration were observed, suggesting an allergic reaction; furthermore, the degenerating striated muscles were noted, which is an uncommon feature in filler granulomas.This may be attributable to a chronic inflammatory or toxic response, leading to muscle degeneration or mass effects from surrounding edema.Additionally, the author reported that the product was used after the expiration date.The symptoms began about a year and a month after the injection date.The event ¿was an allergenic reaction to the product and it is related to the patient factors (immunological reaction) as well as the product.¿ 7 days after the date of onset, patient was started on methylprednisolone for 2 weeks.2 days later patient was injected with hyaluronidase with triamcinolone; a second injection was performed 5 days later.The incisional removal of nodules occurred 20 days later.The granuloma was removed through incision, but there are some scars left on the treatment area.Granuloma resolved 1 month and 4 weeks after the incision.Scar left on the treatment area is still under treatment.
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