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

Catalog Number UNK JUVEDERM VOLUMA XC/LIDO

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

Patient Problems Inflammation (1932); Viral Infection (2248); Subcutaneous Nodule (4548)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm® volbella¿ with lidocaine.(b)(6).(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The events of inflammatory nodule and drainage are a known potential adverse event addressed in the product labeling.The event of covid-19 infection, deemed not device related is considered an unexpected adverse drug experience.

Event Description

Healthcare professional reported that patient was injected with 2ml juvéderm® voluma¿ with lidocaine, 1ml juvéderm® volift¿ with lidocaine, and 1ml juvéderm® volbella¿ with lidocaine.One month later, patient was injected with 1ml juvéderm® voluma¿ with lidocaine in middle third of face and 3ml juvéderm® volux¿ in chin and jaw.Two months later, patient developed induration and sensitivity in chin, "which was interpreted as etip (late and persistent edema).Patient was treated with prednisone.Symptoms improved.Ten days later, patient had covid-19 and developed "intense erythema" on chin and jaw and nodule.Patient was treated with prednisone and clarithromycin.One month later, symptoms worsened.Patient was treated with prednisone 20mg for 5-7 days, lisinopril 10mg for 5 days, clarithromycin, and ciprofloxacin - a total of 3 weeks of antibiotics.Approximately four weeks later, nodules and erythema remained.Clarithromycin and ciprofloxacin were discontinued.Patient was given 1 ampule of diprospan.One day later, "some lesions fistulated, with outflow of purulent material." patient underwent an ultrasound which showed "multiple foci of collection in the lower third and also in the middle third of the face.The physician punctured some foci of the lower third, for drainage and washing, and mentioned output of putrefied hyaluronic acid." patient was treated with 70,000 utr of hyaluronidase (biometil + reductonidase).However, the filler was not dissolved.The secretion was sent for culture - awaiting results.This is the same event and the same patient reported under mdr id # 3005113652-2022-00074 (allergan complaint # (b)(4)), mdr id# 3005113652-2022-00075 (allergan complaint # (b)(4)), mdr id # 3005113652-2022-00077 (allergan complaint # (b)(4)), and mdr id # 3005113652-2022-00078 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® voluma¿ with lidocaine.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5., b.6., h.6.

Event Description

Additionally information reported that the "patient is still under treatment for the complications presented, but that the patient is much better, with few foci of collection in the lower third, without spontaneous drainage." patient was scheduled for a "new ultrasound + drainage + lavage + hyaluronidase application (high dose) in these foci that persist in the lower third." the patient is not currently under any other treatment.Cultures came back partially negative.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13501734
• MDR Text Key: 286351597
• Report Number: 3005113652-2022-00076
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• 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
• Treatment: JUVÉDERM® VOLIFT¿ WITH LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female