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

Catalog Number	94154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported being injected in lips, sides of the face, and crow¿s feet with one syringe of juvéderm® ultra xc, two syringes of juvéderm volbella® xc, and one syringe of juvéderm voluma® xc.The patient was concomitantly injected in the forehead with botox®.Days later, the patient¿s lips ¿started getting bigger, it was very painful, and the left side of the face was swollen.¿ the patient was instructed to take arnica, but the ¿pain¿ kept getting worse.The patient visited the er, who notified the patient that the event was ¿a bad infection called cellulitis.¿ the patient was treated with iv and oral antibiotics.The patient reported that the ¿swelling has gone done¿ but a ¿big bump¿ remains.Additionally, the healthcare professional additionally reported that the patient called the office and reported the event 9 days post-injection and scheduled a follow up.The following day, the patient was advised to take arnica before the follow up.Three days later, the patient reported that they were treated at the er.The healthcare professional added that ¿the following day after the er visit, the inflammation went down but the nodules were still there, since the patient is prone to cold sores.¿ it was not believe that the event is cellulitis because "cellulitis doesn¿t go down in 24 hours and it would infect the whole area.¿ the event is ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2021-03451 (allergan complaint #(b)(4)) and mdr id # 3005113652-2021-03452 (allergan complaint #(b)(4)).This mdr is being submitted for the first suspect product, juvéderm® ultra xc.
Additional Manufacturer Narrative
Suspect product: lot # 918.Concomitant therapies: botox®.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.This is a known potential adverse event addressed in the product labeling.

• Brand Name: JUVEDERM ULTRA 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12968300
• Report Number: 3005113652-2021-03450
• Device Sequence Number: 4423634
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 10/16/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB10384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2021
• 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: JUVÉDERM VOLBELLA® XC, JUVÉDERM VOLUMA® XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female