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Catalog Number 94155 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971)
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Event Date 11/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Patient reported to have been treated with unspecified juvéderm®.The patient has had problems for 2 years since the injection.The patient developed ¿necrotic masses¿ in the face.The patient added, ¿they had the veins cut out and they all gravitated to my neck¿ and ¿i¿ve had a lot of injury and infection constantly¿.The symptoms have not resolved.Additionally, patient reported surgeries to correct damages from deep infections at the injection sites.Additionally, healthcare professional (hcp) reported that the patient was injected in the right jawline, cheek, and in the left nasolabial fold with 1 cc of juvéderm® ultra plus xc.Almost 3 weeks later, the patient was injected with 1.0 ml of juvéderm® ultra plus xc in the left medial cheek scarred rhytid area.The symptoms began on the following month.The hcp reported that infections at the injection site, they all gravitated to my neck, and veins cut out did not occur at the injection sites.The hcp reported that ¿necrotic masses¿ did occur at the injection site.The hcp additionally reported ¿picker¿s nodules multiple sites¿ and ¿persistent eroded and crusted indurated nodules¿ at all sites injected during the first injection, right jawline and cheek and left nasolabial fold.In the physician¿s opinion, some of the reactions are related, biopsy proven.About 4 months after the date of onset, excisional biopsies were performed.These showed foreign body reaction consistent with reaction to hyaluronic acid, ¿+ relationship¿.¿some other sites not related e.G.Mucocele (on bx) removed [about 2 months later.] other¿s were picker¿s nodules¿.This excisional biopsy had a ¿questionable causal relationship¿.It was clarified that the ¿surgeries to correct damages¿ were referring to excisional biopsies.About 2 years later, the patient had dermabrasions and injection with restylane®.3 weeks later, the patient had dermabrasions.Over 3 weeks later, the patient had dermabrasions.Over 2 weeks later, the patient had dermabrasions.Over a month later, the patient had dermabrasions.The symptoms have not fully resolved.The event has led to permanent damage: persistent scars after excisional surgeries with contour deformities due to soft tissue loss (fat atrophy).The patient has history of picker¿s nodules.The hcp added that there is a component of previous radiotherapy damage possibly to lower cheek areas on ¿ex bx¿ from about 3 years prior to the injections and several other subsequent ¿exbx¿ done the previous year and the year after that.This is the same event and the same patient reported under mdr id # 3005113652-2019-00642 (allergan complaint # (b)(4)).This mdr is being submitted for the second injection with suspect product, juvéderm® ultra plus xc.
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformance's noted.Additional data: b.5., b.7., c., d.1., d.4., g.1., h.4., h.6.
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Event Description
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Additionally, the healthcare professional (hcp) clarified what was meant by indicating that ¿infection implantation site¿, ¿they all gravitated to my neck¿, and ¿veins cut out¿ did not occur at the injection.The hcp noted, ¿no named veins were excised but reticular veins would have been removed with the excisions.Many necrotic small ulcerations were present prior to use of juvéderm and afterwards.Some may have been due to prior xrt injury, some clinically were ¿picker¿s nodules¿ and some were foreign body reactions to ha filler as defined by histopath evaluation.¿ the hcp added, ¿infection at the implantation sites not noted¿ and ¿they did not gravitate to the neck ¿ but foreign body reaction extended to jawline area.¿.
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Search Alerts/Recalls
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