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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLBELLA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 06/29/2020
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 event of "vascular occlusion" 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 not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Health professional reported injecting a patient in the lips with juvéderm volbella® xc. One week later, the patient reported ¿strange sensation¿ in the lips, ¿some pain and blanching¿ at the vermillion border. The patient was diagnosed with ¿vascular occlusion¿ and was injected with hylenex right away. The hylenex treatment was continues daily for the following 10 days. The blanching subsided, the pain resolved, and the other sensations resolved as well. The patient was counseled to use a warm compress. By the next month, the patient had ¿full, normal sensation (without pain) with transient hypopigmentation at the occlusion site. ¿ the event has resolved.
 
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Brand NameUNK VOLBELLA
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 Key10387209
MDR Text Key202349501
Report Number3005113652-2020-00450
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,health
Reporter Occupation Physician Assistant
Type of Report Initial
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLBELLA
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 Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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