ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE
|
Back to Search Results |
|
Catalog Number 94151ED |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abscess (1690); Cyst(s) (1800); Skin Irritation (2076)
|
Event Date 04/26/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
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.
The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
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.
|
|
Event Description
|
Healthcare professional reported injecting a patient with a juvederm voluma with lidocaine in the cheeks (ck1, ck2).
Patient returned to the clinic and notified the clinic that they had the filler surgically removed, surgical drainage, about 7 months post-injection due a to pain and a palpable cyst 6 weeks prior from the left side cheek.
Six weeks prior to that, the patient had developed symptoms of pain and an abscess on the left side.
Patient had been told it was due to delayed onset nodule.
Patient had not come back to the clinic earlier as they were embarrassed.
When the patient was reviewed, it was found that the patient had an abscess drained via incision and drainage on the left side medial to orbicularis occuli.
The product had not been injected in that area.
Patient also noted sporadically having flare ups under the orbicularis occuli on the right side that were painful to the touch.
There were no flare ups at the time of the review.
Patient was given some healite yellow.
The patient's face and hands were dry and flaky at appearance.
Hyalase has been used on the right side.
The left side abscess has resolved.
¿on the right side of the face ongoing¿.
Patient additionally noted that they suffer with sinus on occasion.
|
|
Search Alerts/Recalls
|
|
|