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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94640
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2019
Event Type  malfunction  
Manufacturer Narrative
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 that during an injection of one syringe of juvéderm voluma® xc, the ¿product wouldn¿t go through the syringe¿.There was patient contact.There were no injuries.The packaged needle was used and it was tightened by hand.
 
Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
 
Event Description
Healthcare professional reported that during an injection of one syringe of juvéderm voluma® xc, the ¿product wouldn¿t go through the syringe¿.There was patient contact.There were no injuries.The packaged needle was used and it was tightened by hand.
 
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Brand Name
JUVEDERM VOLUMA XC 27G 2 X 1ML
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR  74370
MDR Report Key8317732
MDR Text Key138142246
Report Number3005113652-2019-00097
Device Sequence Number1
Product Code LMH
UDI-Device Identifier30888628000012
UDI-Public30888628000012
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/11/2019
Device Catalogue Number94640
Device Lot NumberVB20A80070
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/07/2019
Supplement Dates Manufacturer Received02/19/2019
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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