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 Edema (1820); Skin Irritation (2076)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.(b)(4).The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.

Event Description

Health professional reported injecting a patient in the cheeks with 3 syringes of juvéderm voluma® xc.Seven days later, the patient was injected in the left cheek with 2 syringes of juvéderm voluma® xc.Two days later, the patient was injected both cheeks with 3 syringes of juvéderm voluma® xc.Nineteen days later, the patient was injected in the lip lines with 1 syringe of juvéderm voluma® xc.Eight weeks later, the patient the patient reported ¿infection¿ in the cheeks.The patient was evaluated by the injector, who noticed ¿lumps¿ on the left cheek that were ¿tender to the touch.¿ the injector offered to ¿reverse it¿ but the patient declined.The patient was treated with drainage and put on antibiotics as a precaution.Three weeks later, the patient reported no improvement and being worse, stating that they were draining the lumps themselves at home.The injector observed ¿a lot of edema¿ on the cheeks and down the neck and treated the patient with 2 antibiotics, including biaxin, and steroids as a precaution.The patient previously experiencing the same event years ago in a prior injection.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2020-00435 (allergan complaint # (b)(4)) and mdr id# 3005113652-2020-00436 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm voluma® xc.

• 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: 10396350
• MDR Text Key: 202580615
• Report Number: 3005113652-2020-00434
• 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
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: 94640
• Device Lot Number: VB20A90490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR