MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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 the patient in the midface 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.The patient experienced ¿swelling.¿ no complaint was made against the juvéderm® vollure¿ xc.Seven months later, the patient injected was injected in the 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 non-device related ¿loss of taste and smell¿ during treatment time following incident of ¿inflammation and antibiotic treatment¿ a month and "induration, firmness" and "erythema," all at the injection site.The patient admitted to non-device related ¿uti¿ and was unvaccinated but tested negative in a pcr covid-19 test done 2 months later.The patient was treated with biaxin 250 mg bid but was discontinued due to "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.This is the same event and the same patient reported under mdr id# 3005113652-2021-03269 (allergan complaint #: (b)(4)) and mdr id# 3005113652-2021-03302 (allergan complaint #: (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® vollure¿ xc (lot: v17lb00418).

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 12586947
• MDR Text Key: 275159316
• Report Number: 3005113652-2021-03303
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Catalogue Number: 95661
• Device Lot Number: V17LB00418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR