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	Swollen Lymph Nodes/Glands (4432)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported they received an injection of botox cosmetic, and then on a later date soon after, an injection of an unspecified juvéderm®.Patient ultimately received a second botox cosmetic injection approximately three months later after these first injections and the next day had "severe neck pain" and reported their "lymph node on the right side got swollen".Patient reported that the neck pain had started improving, but at 10 days after the symptoms began, it had gotten worse and they were "having trouble turning [their] head without pain.At this same time, it was noted that the swelling of the lymph node had improved, but was still slightly swollen.Symptoms ongoing.
Additional Manufacturer Narrative
Clarification: injection date was noted as end of (b)(6) 2021.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Additional information received noting patient was injected with unspecified juvéderm® 26 days after the initial injection of botox®.Four months later, patient received the 2nd injection of botox® and reported the events were against the 2nd botox® injections.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received from the healthcare professional noting the juvéderm® injection was 1ml of juvéderm® ultra xc into the nasolabial folds, oral commisures, and resting crease on glabella.Healthcare professional reported that the patient returned to office a week after date of onset.They were unable to assess the event as patient did not follow up with the office regarding the event.When they saw the patient, the event already resolved.

• 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: 13545651
• Report Number: 3005113652-2022-00090
• Device Sequence Number: 14756321
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2022

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: 04/30/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 03/10/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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: BOTOX.
• Patient Age: 51 YR
• Patient Sex: Female