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

Catalog Number 94728ZQ

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

Patient Problem Autoimmune Disorder (1732)

Event Date 09/22/2021

Event Type  Injury  

Event Description

Healthcare professional reported injecting a patient with 4 syringes of juvederm® voluma¿ xc and 1 syringe of juvederm® volift® xc at t1, ck1, 3, 4, jw4, c1, 6 + ru lip, rl lip, lu lip, ll lip, and the columns above the lips.Approximately a month later, the patient was injected with another 4 syringes of juvederm® voluma¿ xc and 1 syringe of juvederm® volbella¿ xc at t1, ck3, ck4, jw2, jw4/5, c1, nlf, ios.Two months later, the patient had 5cc of juvederm® voluma¿ xc and 1cc of juvederm® volift® xc injected at t1, ck1, ck3, ck4, jw2, jw3, jw4/5, c1, c2, c6 , nlf, + ru lip, rl lip, lu lip, ll lip and the columns above the lips.3 months later, the patient began experiencing cold like symptoms, deemed not related to the device.The patient was tested for covid-19 and the test was negative.However, patient reported being very ill.Approximately 2 weeks later, the patient developed nodules on both sides of the chin as well as in the lip.2 weeks later, the patient was seen by the physician as they were concerned and the areas were massaged.Follow-up was performed with the patient who noted feeling slightly better, but the nodules are still present and irritating and tender to the touch.It was further reported patient "has celiac disease," deemed not related to the device.Patient is also prescribed an asthma inhaler.The event is ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2021-03375 (allergan complaint (b)(4)), mdr id # 3005113652-2021-03376 (allergan complaint (b)(4)), mdr id # 3005113652-2021-03378 (allergan complaint (b)(4)), mdr id # 3005113652-2021-03405 (allergan complaint (b)(4)).And mdr id # 3005113652-2021-03406 (allergan complaint (b)(4)).This mdr is being submitted for the third injection of first suspected product, juvederm voluma xc.This mdr is being submitted for the third suspected product, juvederm volbella xc.

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 of "celiac disease" 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.The event of "celiac disease", deemed not device related is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported injecting a patient with 4 syringes of juvederm® voluma¿ xc and 1 syringe of juvederm® volift® xc at t1, ck1, 3, 4, jw4, c1, 6 + ru lip, rl lip, lu lip, ll lip, and the columns above the lips.Approximately a month later, the patient was injected with another 4 syringes of of juvederm® voluma¿ xc and 1 syringe of juvederm® volbella¿ xc at t1, ck3, ck4, jw2, jw4/5, c1, nlf, ios.Two months later, the patient had 5cc of juvederm® voluma¿ xc and 1cc of juvederm® volift® xc injected at t1, ck1, ck3, ck4, jw2, jw3, jw4/5, c1, c2, c6 , nlf, + ru lip, rl lip, lu lip, ll lip and the columns above the lips.3 months later, the patient began experiencing cold like symptoms, deemed not related to the device.The patient was tested for covid-19 and the test was negative.However, patient reported being very ill.Approximately 2 weeks later, the patient developed nodules on both sides of the chin as well as in the lip.2 weeks later, the patient was seen by the physician as they were concerned and the areas were massaged.Follow-up was performed with the patient who noted feeling slightly better, but the nodules are still present and irritating and tender to the touch.It was further reported patient "has celiac disease," deemed not related to the device.Patient is also prescribed an asthma inhaler.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2021-03375 (allergan complaint (b)(4)), mdr id# 3005113652-2021-03376 (allergan complaint (b)(4)), mdr id# 3005113652-2021-03378 (allergan complaint (b)(4)), mdr id# 3005113652-2021-03405 (allergan complaint (b)(4)).And mdr id# 3005113652-2021-03406 (allergan complaint (b)(4)).This mdr is being submitted for the third injection of first suspected product, juvederm voluma xc.This mdr is being submitted for the third suspected product, juvederm volbella xc.

• Brand Name: VOLBELLA 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12798954
• MDR Text Key: 281989028
• Report Number: 3005113652-2021-03377
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 94728ZQ
• Device Lot Number: V15LA90333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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: JUVEDERM® VOLUMA¿ XC, ASTHMA INHALER.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 45 KG