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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96183
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/15/2020
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was discarded. 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported a patient was injected with 2 syringes of juvéderm voluma® xc in the cheeks, 2 syringes of juvéderm® ultra plus xc in the marionette lines and oral commissures, and 1 syringe of juvéderm volbella® xc in the upper lip and lines around the upper lip. Two weeks later, patient came back and was injected with 1 syringe of juvéderm volbella® xc in the lower lip. Approximately less than 2 months later, patient reported they experienced bumps, hard subcutaneous nodules above the upper lip, 1 bump under their right eye in the medial cheek, and 1 bump in the lower lips. Patient also stated they had a cold (deemed not related to the device) the week before. Healthcare professional believed patient had experienced biofilm, without a biopsy to confirm. Per physician, the biofilm might be caused by "a cold virus. " a cbc test was performed and came back with slightly elevated neutrophils. Patient was treated with a steroid injection of triamcinolone, prescribed a methylprednisolone dose pack, and prescribed clarithromycin. Event is ongoing. This is the same event and the same patient reported under mdr id # 3005113652-2020-00790 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00791 (allergan complaint # (b)(4)), and mdr id # 3005113652-2020-00792 (allergan complaint # (b)(4)). This mdr is submitted for the forth suspect product, juvéderm volbella® xc.
 
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Brand NameVOLBELLA WITH LIDOCAINE
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 Key11043655
MDR Text Key222641140
Report Number3005113652-2020-00793
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/09/2021
Device Catalogue Number96183
Device Lot NumberV15LA90370
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 Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2020 Patient Sequence Number: 1
Treatment
"A LOT OF VITAMINS"
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