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

Catalog Number 96637RX

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

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

Event Date 05/31/2021

Event Type  Injury  

Event Description

Patient, who is also a healthcare professional, reported they were injected with 0.5 ml of juvéderm® volux¿ in jw1 and ck2.Two weeks later, patient was then injected with juvéderm® voluma¿ with lidocaine with 0.2ml in the nl1 and 0.5ml in the ck1.About two and a half months after the second injection, patient received the first dose of the pfizer covid vaccine and was asymptomatic at this time.Patient received the second dose about four weeks later and had "pain at facial puncture sites jw1 and ck2, with discrete swelling, diarrhoea, headache and fever." a month and a half after the second dose, patient was then injected in the zone jw1 with 0.5 ml of juvéderm® volux¿.Four months after the injection, patient had an "appearance of nodule in zygomatic arch and left malar in increasing volume and enlargement of neighbouring soft tissues" and "eyelid oedema, facial pain in zygoma and mandible and facial deformity." "compromised maceteric and left buccal parotid" was also noted.Healthcare professional "started symptomatic treatment with ultrasound (data compatible with oedema and subcutaneous cellular inflammation) with normal results for parotid, stenotic lithoid or viral lesion." ten days later, it was noted "ia does not give ia results, switches to steroids betamethasone 8 mg im which reduces approx.80% of the volume." 8 days following the switch to steroids, a "recurrence of inflammation in contralateral section (involvement of both hemispheres), additional inflammation of zygomatic arch, forehead, mentonian region and mandibular angle" was noted.Biochemical tests were performed to broaden the diagnosis and all came back normal.The next day, a mri was conducted "with presence of collections due to probable placement of material in both zygomatic arches with traces of oedema with extension to the masseters, predominantly on the left." three days later, a second dose of betamethasone 8mg im was given with partial response of two days.On the next day, patient was referred to rheumatology with possible diagnosis of disease "due to modelling/adjuvants." the treatments of "tx prednisone 40 mg / 24hrs, 25 mg methotrexate / 24hrs and 1500 u subcutaneous hyaluronidase" were initiated on this date.Event has not resolved.

Manufacturer Narrative

(b)(4).Clarification: 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.

• Brand Name: JUVEDERM 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13079369
• MDR Text Key: 287821933
• Report Number: 3005113652-2021-03489
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 96637RX
• Device Lot Number: VB20B10056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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® VOLUX¿.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male