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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96181
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2020
Event Type  malfunction  
Manufacturer Narrative
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. Further information regarding event, product, or patient details has been requested. No additional information is available at this time.
 
Event Description
Healthcare professional reported that during injection with one syringe of juvéderm volbella® xc, "it was noticed that the product had a hard-white object floating in the product within the syringe. " patient contact occurred. There were no injuries to patient or injector. The allergan packaged needle was used and tightened by hand. This was confirmed the initial use of the syringe.
 
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Brand NameJUVEDERM VOLBELLA XC 2 X 1ML 32G
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key10316029
MDR Text Key200292221
Report Number3005113652-2020-00415
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2021
Device Catalogue Number96181
Device Lot NumberV15LA90351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2020 Patient Sequence Number: 1
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