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

Catalog Number UNK VOLBELLA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional (hcp) reported patient was injected with 1 ml of juvéderm® volbella¿ with lidocaine in the lips for volume.During the injection process, a hematoma was created with the possibility of embolism of the inferior labial artery.

• Brand Name: UNK VOLBELLA
• Type of Device: IMPLANT, 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 14981575
• MDR Text Key: 295681097
• Report Number: 3005113652-2022-00429
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR