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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 Angioedema (4536)
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 not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reports patient injection with an unknown number of syringes of juvéderm volbella® xc in the lips. Patient received a pfizer covid vaccine an unspecified amount of time later and developed ¿angioedema¿ at the injection site. The symptoms have been 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
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 
7372473605
MDR Report Key11530809
MDR Text Key249664231
Report Number3005113652-2021-00147
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
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 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
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 Received02/22/2021
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 Unkown

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