MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	96183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting a patient in the lips with half a syringe of juvéderm volbella® xc.Four months later, the patient was injected in the lips with another half of a syringe of juvéderm volbella® xc.A month later, the patient reported ¿tender and painful nodules¿ on the lips.The patient was prescribed a medrol dosepak, which worked but once it ceased, the event returned.Eleven days later, the patient was prescribed another medrol dosepak and doxycycline.After 2 week, the patient¿s lips were ¿less inflamed,¿ but the event would return after ceasing medication.The patient was treated that day with 2 vials of hylenex and prescribed more doxycycline.Three weeks later, it was noted that the patient had no redness and less inflamed lips, but the nodules remained.The patient reported ¿swelling¿ the next day.After 7 weeks, the nodules were no longer visible, but the patient reported that a different area of their lips would ¿swell¿ every couple of days and ¿las a couple of hours." the patient was treated that day with 2 vials of hylenex.After 2 weeks, the patient reported that ¿random swelling¿ in the lips remained.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2023-00750 (abbvie complaint #pr (b)(4)).This mdr is being submitted for the second suspect product, juvéderm volbella® xc.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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.
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: the syringe has been discarded.
Event or Problem Description
Additionally, the healthcare professional reported that the patient was treated with biaxin and a medrol dosepak half a month after the hylenex and doxycycline treatment.

• Brand Name: VOLBELLA WITH LIDOCAINE
• 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: 17747161
• Report Number: 3005113652-2023-00751
• Device Sequence Number: 17556176
• Product Code: LMH
• UDI-Device Identifier: 10888628043565
• UDI-Public: 10888628043565
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 08/14/2023
• Device Catalogue Number: 96183
• Device Lot Number: V15LB10865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female