MAUDE Adverse Event Report: PRINGY VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	96183
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information 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 or Problem Description
Healthcare professional (hcp) reported injecting a patient with juvéderm® volbella® xc.Patient experienced vascular occlusion.Hcp treated the patient with "several vials" of hylenex to "dissolve the product".Symptom resolution is unknown.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
Additionally, healthcare professional (hcp) reported patient was injected using a bd syringe and experienced a vascular occlusion of the left lower lip occurred 2 days post-injection diagnosed via ultrasound.Patient was treated with 38 vials of hylenex, valtrex 500 mg bid, and doxycycline 100 mg 2 days post injection.Hcp treated the patient the following day with 6 hyperbaric oxygen 90min sessions.The next day, the patient began a 7 day treatment with a poratal oxygen skin device.Hcp additionally commented that after the hylenex treatment, "product moved from left inferior labial artery to bilateral submental and bilateral mental arteries".Patient went to a second physician for further dissolving with an ultrasound.Symptoms resolved.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22654105
• Report Number: 3005113652-2025-00689
• Device Sequence Number: 8654172
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: (01)10888628043565(10)1001773735(11)240514(17)260414
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2026
• Device Catalogue Number: 96183
• Device Lot Number: 1001773735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White