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

Catalog Number 96637JR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

Continued h.6.Health effect - impact codes: f2203.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 Description

Healthcare professional (hcp) reported a patient was injected with [unspecified] juvéderm® voluma¿ into ck1, ck2, ck3 and juvéderm® volift¿ into nl1, nl2, nl3.Four months later patient went to the dentist for a filling in left upper gum and went to bed face still frozen from aesthetic.Next day, patient experienced painful and swollen in left cheek with a hard lump of marble size.Next day, patient went back to the dentist and was told they has saliva gland infection and prescribed penicillin.Two days later, x-ray performed but result was not provided.Next day, dentist changed antibiotics to tetracycline as symptom has not resolved.Four days later, a short course of steroids 30mg was added for 6 days.Patient still has the lump high in gum line.The cheek area has completely resolved.The lump is not sore to touch but she does occasionally get a dragging feeling from it.This is the same event and the same patient reported under mdr id# 3005113652-2023-00761 (abbvie complaint #pr (b)(4)).This mdr is being submitted for the suspect product, [unspecified] juvéderm® voluma¿.

Manufacturer Narrative

The event is deemed not device related.The event is an expected adverse drug experience, therefore, it did not meet reporting requirements aligned with us combination product reporting for medical devices.

Event Description

Additional information reporting patient has been seen by maxillofacial noting the event of infection is due to trauma form the dental local anesthetic injection, also reassured the patient this was not related to dermal filler.

• Brand Name: JUVÉDERM VOLUMA WITH LIDOCAINE
• 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: 17785815
• MDR Text Key: 323891749
• Report Number: 3005113652-2023-00760
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 05016007208092
• UDI-Public: 5016007208092
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 96637JR
• Device Lot Number: VB20B00928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2020
• 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
• Treatment: JUVÉDERM® VOLIFT¿.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female