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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 94731RX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 05/11/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record has been completed. No deviations or non-conformances noted. The event of is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional (hcp) reported vascular occlusion on the lips during injection in the lips with juvéderm® volbella¿ with lidocaine. The hcp calmed the patient ¿from the problem caused on the lip¿. On the same day, patient was treated with hyaluronidase and corticosteroids. Patient was given nifedipine and acetylsalicylic acid to take home. Patient was also given cicaplast® ¿because it regressed the edema and dried the lip, and there is the bruise¿. ¿patient is sacred if [they] will get better. ¿ 7 days later the patient was ¿better and calmer¿. There was still ¿livedo¿ present. The symptoms have not resolved.
 
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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 Key10149833
MDR Text Key195023112
Report Number3005113652-2020-00325
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue Number94731RX
Device Lot NumberV15LA80437
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 Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/12/2020 Patient Sequence Number: 1
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