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

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.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Type of Device: IMPLANT, 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 Key: 10149833
• MDR Text Key: 195023112
• Report Number: 3005113652-2020-00325
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• 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 Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA80437
• 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 Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

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