MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA WITH LIDOCAÏNE 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96180JS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Subcutaneous Nodule (4548)

Event Date 01/15/2022

Event Type  Injury  

Event Description

Healthcare professional reported a patient was pretreated with topical emla and injected with 0.8mls of juvéderm® volift¿ with lidocaine on the lips and 1ml of juvéderm® volbella¿ with lidocaine in the "barr code" region.Patient was given ice and pain killers for the next 24 hours posttreatment.About a month after the first injection, patient received a third dose of a covid 19 vaccine from moderna.About three weeks later, patient felt that their lip had hardened.Patient consulted with the clinic 15 days later and clinic noted patient had "granulomas.", biopsy was not provided.Patient started treatment with dacortin 30mg, ciprofloxacin 400mg, claritromicin 500mg, and ebastina 20 mg.It was noted there was slow disapparition of symptoms and weekly control.About a month after the symptoms began, induration was present again and patient was treated with hyaluronidase injection.Another hyaluronidase injection was done two weeks later and it was noted the patient was better.Event is still ongoing.This is the same event and the same patient reported under mdr report # 3005113652-2022-00110 (allergan complaint # (b)(4)).This mdr is being submitted for the first suspect product, juvéderm® volbella¿ with lidocaine.

Manufacturer Narrative

Concomitant therapies: emla (pre-treatment), pain killers and ice (post-treatment), and eutirox 75 mg.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 Description

Additional information received noting events resolved about two months after date of onset.

• Brand Name: JUVEDERM VOLBELLA WITH LIDOCAÏNE 32G
• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13605855
• MDR Text Key: 286437497
• Report Number: 3005113652-2022-00101
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 04/08/2022

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: 03/31/2023
• Device Catalogue Number: 96180JS
• Device Lot Number: V15LB10263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLIFT¿ WITH LIDOCAINE,
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female