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	Nodule (4551)
Date of Event	10/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting a patient in the cheeks with juvéderm® voluma¿ xc.Sixteen months later, the patient was injected in the marionettes and nasolabial folds with juvéderm® ultra.A month later, the patient was injected in the chin with restylane® lyft and sculptra aesthetic.A month and a half later, the patient was injected in the marionettes and nasolabial folds with juvéderm® vollure¿ xc.The patient experienced ¿inflammation and nodules¿ to the face 3.5 months later.The patient was treated with doxycycline, ciprofloxacin, and medrol dosepak.The event is ongoing but ¿improving.¿ this is the same event and the same patient reported under mdr id # 3005113652-2022-00174 (allergan complaint # (b)(4)) and mdr id # 3005113652-2022-00176 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra.
Event or Problem Description
Additional information reported six days after symptom onset, patient was treated with 5 fu/dexa/kenalog injection to 4 large nodules.10 days later, patient restarted doxycycline and clarithromycin for 2 weeks.Three days later, 5 fu/dexa/kenalog was injected to new nodules.Four days later, 7 vials hylanex and kenalog were injected into cheek nodules.Approximately three months later, symptom resolved.
Additional Manufacturer Narrative
Continued h6: type of investigation code: b18.Clarification to h6: the syringe has been discarded.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.

• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 13862794
• Report Number: 3005113652-2022-00175
• Device Sequence Number: 11935159
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 04/12/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female