Catalog Number 96181 |
Device Problems
Difficult or Delayed Positioning (1157); Expulsion (2933)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/27/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Further information 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 1 syringe of juvéderm volbella® xc had a "large amount of pressure" when trying to inject, and the product ended up blowing out "the opposite end" and the product "was coming out where the needle attaches".Patient contact occurred.No injuries were reported.The packaged needle was used.
|
|
Manufacturer Narrative
|
A review of the device history record has been completed.No deviations or non-conformances noted.
|
|
Event Description
|
Healthcare professional reported 1 syringe of juvéderm volbella® xc had a "large amount of pressure" when trying to inject, and the product ended up blowing out "the opposite end" and the product "was coming out where the needle attaches." patient contact occurred.No injuries were reported.The packaged needle was used.
|
|
Search Alerts/Recalls
|