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

Catalog Number	96183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	02/23/2026
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.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.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient in the chin (mentum) with 1ml of juvéderm® voluma® xc.Four months post-injection patient returned to the injecting clinic experiencing "palpable nodules in the mentum, clinically suggestive of product migration".On the same day, patient was treated with 1 vial hylenex, reconstituted with 0.2ml sodium bicarbonate and 0.2ml of 2% lidocaine.During the treatment appointment patient was also injected with 0.5ml of juvéderm® volbella® xc to the upper lip.One month later, patient reported "intermittent swelling of the bilateral jawline and chin since treatment.Swelling is fluctuating, with episodes of resolution and recurrence".Patient also experienced "episodic swelling of both upper and lower lips, described as firm when present.No swelling or firmness observed on exam".Hcp noted their clinical finds as the "chin appears tight, firm, and somewhat rigid in contour", the "right jawline/jowl demonstrates fullness consistent with possible product migration", and the "left jawline/jowl without palpable firmness or visible swelling on exam, though patient reports intermittent symptoms of episodic swelling and firmness".Patient reported increased non-device related work stress.Hcp later reported patient experienced [non-device related] trauma to the lower lip by "another person biting [their] lip 4 weeks post injection".Symptoms are ongoing.This was the initial use of the syringe.The packaged needle was used.This relates to juvéderm® volbella® xc.

• 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: 24969415
• Report Number: 3005113652-2026-00397
• Device Sequence Number: 12010026
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: (01)10888628043565(10)1004236540(11)250520(17)270420
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 96183
• Device Lot Number: 1004236540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic