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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE
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ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94151ED
Device Problems Gel Leak (1267); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2018
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.
 
Event Description
Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the cheek area with the packaged needle.While using the syringe, it started to leak from the hub at the top and could not be contained in the syringe.Healthcare professional feels that the syringe itself was defective and unable to contain the needle.The top hub part was clearly snapped.There were no injuries.
 
Manufacturer Narrative
Device history record found no significant anomalies.No deviations or non-conformances were found.
 
Event Description
Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the cheek area with the packaged needle.While using the syringe, it started to leak from the hub at the top and could not be contained in the syringe.Healthcare professional feels that the syringe itself was defective and unable to contain the needle.The top hub part was clearly snapped.There were no injuries.
 
Manufacturer Narrative
Lab analysis of the device found one empty syringe of 1.0 ml, received without tray, needle and cap.No defect is observed on the syringe.
 
Event Description
Healthcare professional reported injecting a patient with juvéderm voluma with lidocaine in the cheek area with the packaged needle.While using the syringe, it started to leak from the hub at the top and could not be contained in the syringe.Healthcare professional feels that the syringe itself was defective and unable to contain the needle.The top hub part was clearly snapped.There were no injuries.
 
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Brand Name
JUVEDERM VOLUMA WITH LIDOCAINE 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 Key8202277
MDR Text Key131584899
Report Number3005113652-2018-01793
Device Sequence Number1
Product Code LMH
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,foreig
Type of Report Initial,Followup,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Catalogue Number94151ED
Device Lot NumberVB20A80443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2019
Date Manufacturer Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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