MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE

Device Problem Off-Label Use (1494)

Patient Problem Angioedema (4536)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: munavalli, girish gilly, et al.¿covid-19/sars-cov-2 virus spike protein-related delayed inflammatory reaction to hyaluronic acid dermal fillers: a challenging clinical conundrum in diagnosis and treatment.¿ archives of dermatological research, 09 feb 2021.Crossref, doi:10.1007/s00403-021-02190-6.Allergan is unable to gather additional event, product, or patient details as contact information was not provided in the article.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.This is the same article reported under mdr id# 3005113652-2021-00161 allergan complaint # (b)(4) and mdr id# 3005113652-2021-00160 allergan complaint # (b)(4).

Event Description

Journal article ¿covid-19/sars- cov-2 virus spike protein-related delayed inflammatory reaction to hyaluronic acid dermal fillers: a challenging clinical conundrum in diagnosis and treatment¿ reported a patient case 3 experienced ¿generalized myalgias and fever of 101.6 f more than one year post injection into the bilateral tear troughs with juvederm voluma and into the upper and lower lip with juvéderm ultra and 12 hours after vaccination for covid-19 with moderna vaccine.500mg of acetaminophen was taken for symptom management with resolution of fever the following morning.The patient then experienced increased tenderness in the right tear trough, throughout the day, the unilateral infraorbital edema worsened and perioral edema began to develop.36h post vaccination, 10mg of certirizine was administered.The patient reported 48h post vaccination infraorbital swelling and perioral angioedema was at its peak and she was unable to open the right eye and throughout the morning, the left tear trough swelling subjectively increased, while the rest of the face remained persistently swollen, in areas of previous filler injection¿.The patient declined corticosteroids and was treated with oral lisinopril.This is the same event and the same patient reported under mdr id# 3005113652-2021-00164 allergan complaint # (b)(4).This mdr is being submitted for the suspect product, juvederm voluma.

• Brand Name: JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN)
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX ; 7372473605
• MDR Report Key: 11457751
• MDR Text Key: 243148707
• Report Number: 3005113652-2021-00163
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA-ADDITIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR