MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK JUVEDERM VOLUX; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUX

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

Patient Problem Urinary Tract Infection (2120)

Event Date 07/06/2021

Event Type  Injury  

Event Description

Healthcare professional reported that a subject is pregnant after they were injected in the chin with juvéderm volux® and ¿elective termination" of the pregnancy.Patient experienced non-serious and non-device related events of qi deficiency, zerophthalmia and spleen stomach damp heat.Patient was treated with traditional chinese medicine(angelica sinensis, rhizoma chuanxiong, leonuri herba), ¿gutong plaster¿, ¿loxoprofen sodium tablets 60mg¿, ¿vitamin b1 10mg¿, ¿mecobalamine 0.5mg¿, ¿gutong plaster¿, ¿mecobalamine 0.5mg¿, ¿gutong plaster." approximately six months post-injection, patient experienced urinary tract infection, deemed not related to the device.Patient was treated with levofloxacin tablets 0.5g.All reported events, except zerophthalmia, have resolved.

Manufacturer Narrative

The event of ¿urinary tract infection¿ (not device related) is considered an adverse drug experience allergan is unable to confirm with the healthcare professional; therefore, additional event, product, or patient details are not attainable the event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event the filler was injected into the patient and is not accessible for return.The syringe was discarded.

• Brand Name: UNK JUVEDERM VOLUX
• 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: 14028351
• MDR Text Key: 291239403
• Report Number: 3005113652-2022-00206
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic