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Catalog Number 96655JR |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Patient reported being injected with unk dermal filler.At the end of the day, patient experienced swellng on the whole jaw and chin, in so much pain, patient couldn't open the mouth.Patient had hard time chewing food.Patient have deformities and decompensated inflammations of the jaw.The next day, patient woke up with same pain and took ibuprofen for inflammation.Symptoms are ongoing.
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Manufacturer Narrative
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Additional, changed, and/or corrected data: a4, a5, a6, b5, d1, d4, g1, g4, h6.
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Event Description
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Additionally, patient reported being injected with juvéderm volux xc and inflammation more in the lower third.They have been treated with corticosteroids.Symptom resolved.
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Manufacturer Narrative
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H.11: previous emdr submission noted the event code inflammation.However, per medical assessment, event code is not serious injury.
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Event Description
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Patient reported being injected with unk dermal filler.At the end of the day, patient experienced swellng on the whole jaw and chin, in so much pain, patient couldn't open the mouth.Patient had hard time chewing food.Patient have deformities and decompensated inflammations of the jaw.The next day, patient woke up with same pain and took ibuprofen for inflammation.Symptoms are ongoing.
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Search Alerts/Recalls
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