MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	94155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting a patient in the subcutaneous plane of the mental crease with 0.15 cc juvéderm® ultra plus xc.The injector went down to the bone and aspirated first to check for vasculature.The patient had ¿initial soreness.¿ approximately 24-48h later, the patient reported ¿pain¿ in the gums and general jaw area and visualized ¿small, pimple-like lesion with pus coming out¿ of the injection site.The patient was treated with doxycycline for 10 days, asa 325, and a warm compress the next day.The patient has a history of back issues and hypothyroidism, a history or previous juvéderm® ultra and juvéderm® ultra plus and takes synthroid concomitantly.The event is ongoing, but the swelling has come down.
Additional Manufacturer Narrative
Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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 noted.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• Common Device Name: 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15886109
• Report Number: 3005113652-2022-00776
• Device Sequence Number: 5250289
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2022
• Device Catalogue Number: 94155
• Device Lot Number: H30LB10427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHROID
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female