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 Problem Urinary Tract Infection (2120)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(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.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.The event of uti, deemed not device related is considered an unexpected adverse drug experience.

Event Description

Health professional reported injecting a patient experienced swelling after getting injection of juvéderm® voluma¿ xc in the midface.Seven months later, the patient was injected with juvéderm® volbella¿ xc and juvéderm® vollure¿ xc.Approximately three months later, patient had urinary tract infection (uti), deemed not device related.Patient also had an "incidence of loss of taste and smell (deemed not device related) during treatment time following incident of inflammation and antibiotic therapy." patient tested negative for pcr covid test.The product was dissolved.This is the same event and the same patient reported under mdr id# 3005113652-2021-03270 (allergan complaint #(b)(4)) and mdr id# 3005113652-2021-03271 (allergan complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvéderm® voluma¿ xc.

Event Description

Additionally, the health professional reported injecting the patient with 1 ml of juvéderm® voluma¿ xc and in the in the submalar, marionettes, chin, and nasolabial folds with 3 ml of juvéderm® vollure¿ xc.Seven months later, patient was injected in the lips, oral commissures, and lip lines with juvéderm® volbella¿ xc, in the chin with 1 cc of juvéderm® vollure¿ xc, and in the chin with 1 cc of juvéderm® voluma¿ xc.The patient also experienced "induration, firmness" and "erythema," all at the injection site.The patient was treated with biaxin 250 mg bid but was discontinued due to non-device related "severe gastrointestinal symptoms." the patient was also given cipro 500 mg bid/minocycline 100 mg qd 14 days, and hylenex to the injected areas.Two months after onset, "the redness abated, no induration, and small nodule remain." the event is ongoing.

• 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
• MDR Report Key: 12540866
• MDR Text Key: 273593633
• Report Number: 3005113652-2021-03269
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: 94640
• Device Lot Number: VB20B01018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLLURE¿ XC, VITAMINS
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR