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

Catalog Number 96637JR

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Abscess (1690); Inflammation (1932); Subcutaneous Nodule (4548)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that a patient was injected with ¿seven months expired¿ juvéderm voluma® xc.A month later, patient had a prescription for amoxicillin, plus they had to pull a ton of pus from the patients left cheek, and the patient is on two different antibiotics as well as steroids.It was noted that the patient is currently having underlying dental issues.Symptoms ongoing.

Manufacturer Narrative

Additional, changed, and/or corrected data.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.

Event Description

Treating physician reported that a patient was injected in the cheeks and mentolabial folds with one vial of each juvéderm voluma® xc and juvéderm® ultra plus xc at another office.Seven days later, patient reported to the injecting office that they experienced mild redness, and pain to touch.Patient was treated with prednisone and amoxicillin (500 mg).Approximately a month later, patient called the injecting office regarding swelling in the eye area with a large amount of facial swelling that appeared overnight.Patient was instructed to get medical treatment at a clinic or an er and was medicated with clindamycin.Patient went to the treating office for treatment approximately three weeks later.Treating physician reported that patient had erythema, edema and firmness on the left cheek, left mentolabial folds over the malar prominence, suspected delayed nodule formation with possible microbiome formation from fillers.Patient was treated with double antibiotic therapy with cipro and clarithromycin as tolerated.The patient did not take the antibiotics.Four days later, patient returned to the treating office with a large abscess on their left malar prominence.Treating physician drained the abscess of approximately 3-4cc of thick, purulent and bloody liquid and was sent for bacterial cultured.Cultured was negative.Patient was advised to start taking the antibiotic prescribed but an adverse reaction to the antibiotics and discontinued the cipro.Nine days later, treating physician drained the abscess again with approximately 2cc.The next day, patient had a ct of the maxillofacial area without contrast.A couple weeks later, patient reported a dimple on their left cheek.The area of previous abscess had tethered down to the bone while the surrounding tissue remained very firm.Treating physician suggested massaging the firm area to try and release the tethering.Patient was advised that would need plastic surgery to correct the scarring.12 days later, patient returned to the office with new abscesses that developed over the previous day or two.They were swollen, but not too tender.The abscess in their left mentolabial crease was drained, sent the purulent material for bacterial and atypical cycobacterial culture.Event is ongoing at this time.This is the same event and the same patient reported under mdr id#: 3005113652-2021-00229 (allergan complaint: (b)(4) this mdr is being submitted for juvéderm voluma® xc.

• 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
• MDR Report Key: 11405318
• MDR Text Key: 234467681
• Report Number: 3005113652-2021-00150
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 96637JR
• Device Lot Number: VB20B00359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PANIDAZOLE, ROSUVASTATIN, VALACYCLOVIR, VALSARTAN.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR