MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

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

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

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 completed.  no deviations or non-conformances identified.This is a known potential adverse event addressed in the product labeling.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional (hcp) reported injecting a patient with 2ml of juvéderm voluma® xc in the cheeks and 0.4ml of juvéderm volbella® xc in the lips.About 6 weeks later, patient allegedly developed an ¿infection¿ in one of their cheeks.Patient is ¿not happy.¿ hcp reported ¿it did have some swelling and redness, but [they] didn't think it was an infection.Usually an infection would occur within 48-72hrs after a procedure, not 6 weeks.At 6 weeks, [they] put [the patient] on antibiotics (bactrim).¿ hcp told the patient to follow up 3-days later.Patient didn't come back for 2 weeks, which is when hcp administered hyaluronidase (about 2 months after the procedure).¿warmth¿ was also reported.A culture was done; results indicated no wbcs or bacteria.A ct scan without contrast was done and there was no fluid collection to suggest abscess.Hcp also recommended motrin as treatment and also provided incision and drainage.Symptoms resolved and patient was left with ¿scarring, loss of volume, and hyperpigmentation.¿.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 9687574
• MDR Text Key: 178534006
• Report Number: 3005113652-2020-00044
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• 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
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A70460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 76 YR