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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Viral Infection (2248)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. A review of the device history record has been completed. No deviations or non-conformances noted. The event of infection - ndr is considered an unexpected adverse drug experience.
 
Event Description
Health professional reported injecting a patient in the lip/perioral area with 1 ml of juvéderm volbella® xc. Three months later, the patient was prepped on the lower side for a dental crown. A week later, the patient reported experiencing ¿hard and tender bumps¿ but no swelling. A week and a half later, the patient started a "doxi antibiotic. " four days later, the patient went back to the dentist and was given novocain and had the crown set on right side. For the following 5 days, the patient¿s lips were very swollen, especially the upper right side. Two days later, the patient was treated with hylenex and prescribed prednisone for 3 days. The patient returned 6 days later for more hylenex. The health professional later reported that the patient was going to be managed by them in the clinic but "got covid. " the patient has since recovered from covid but the injector later contracted covid and was not able to see the patient. The event is ongoing.
 
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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 Key10968126
MDR Text Key220216309
Report Number3005113652-2020-00734
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 Nurse Practitioner
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/26/2021
Device Catalogue Number96181
Device Lot NumberV15LA90358
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No

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