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

Model Number	95834
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Tract Infection (2420); Nodule (4551)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported in the article ¿radial sound (shockwave) therapy resolves delayed-onset nodules following injection of hyaluronic acid dermal filler: a case study¿ that a patient was injected in the cheeks and midface with juvéderm® voluma¿ xc and in the perioral rhytids with juvéderm® volbella¿ xc.Three months later, the patient experienced ¿five circumoral nodules¿ bilaterally in the oral commissures that were not visible but could be detected by palpation.The patient reported that the nodules felt ¿hot and tight¿ under the skin.The patient also reported to have experienced a non-device related ¿upper respiratory infection¿ two weeks before the nodules appeared, but was afebrile upon presentation, with no systemic signs of infection; thus, an infectious etiology was not suspected regarding the nodules.The patient was treated with radial sound technology (rst), 80mj/10hz×2500 pulses per cheek and 1,000 pulses over the upper lip.Immediately after the first treatment, lasting 10 minutes, the patient stated that the nodules felt ¿less tight¿ and were ¿less hot and uncomfortable.¿ immediately post-procedure, the nodules felt smaller and softer on palpation.The patient agreed to return for three additional sessions over the next two weeks and to delay treatment with hyaluronidase or oral corticosteroids.After the fourth rst treatment, the nodules had resolved completely.This is the same event and the same patient reported under mdr id# 3005113652-2022-00185 (allergan complaint #(b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volbella¿ xc.
Additional Manufacturer Narrative
Article citation: ostezan l, peck j."radial sound (shockwave) therapy resolves delayed-onset nodules following injection of hyaluronic acid dermal filler: a case study." j clin aesthet dermatol.2021;14(12 suppl 1):s15¿s17.Pmid: 35291262; pmcid: pmc8903222.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.The event of inflammatory nodule is a known potential adverse event addressed in the product labeling.The event of upper respiratory infection, deemed not device related is considered an unexpected adverse drug experience.
Event or Problem Description
Additionally, the healthcare professional reported injecting the patient with 3 ml of juvéderm voluma® xc and 2 ml of juvéderm® volbella¿ xc.The event "migrated bilaterally to the lower face." the patient was also treated with 800mg of ibuprofen twice a day and the radial sound technology (rst) treatments were a week apart.The event resolved the day of the fourth treatment.
Additional Manufacturer Narrative
Clarification to h6: the filler was injected into the patient and is not accessible for return.The syringe was 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.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.
Event or Problem Description
Healthcare professional reported in the article ¿radial sound (shockwave) therapy resolves delayed-onset nodules following injection of hyaluronic acid dermal filler: a case study¿ that a patient was injected in the cheeks and midface with juvéderm® voluma¿ xc and in the perioral rhytids with juvéderm® volbella¿ xc.Three months later, the patient experienced ¿five circumoral nodules¿ bilaterally in the oral commissures that were not visible but could be detected by palpation.The patient reported that the nodules felt ¿hot and tight¿ under the skin.The patient also reported to have experienced a non-device related ¿upper respiratory infection¿ two weeks before the nodules appeared, but was afebrile upon presentation, with no systemic signs of infection; thus, an infectious etiology was not suspected regarding the nodules.The patient was treated with radial sound technology (rst), 80mj/10hz×2500 pulses per cheek and 1,000 pulses over the upper lip.Immediately after the first treatment, lasting 10 minutes, the patient stated that the nodules felt ¿less tight¿ and were ¿less hot and uncomfortable.¿ immediately post-procedure, the nodules felt smaller and softer on palpation.The patient agreed to return for three additional sessions over the next two weeks and to delay treatment with hyaluronidase or oral corticosteroids.After the fourth rst treatment, the nodules had resolved completely.This is the same event and the same patient reported under mdr id# 3005113652-2022-00185 (allergan complaint #(b)(4).This mdr is being submitted for the second suspect product, juvéderm® volbella¿ xc.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13955688
• Report Number: 3005113652-2022-00186
• Device Sequence Number: 4186501
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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: 01/22/2019
• Device Model Number: 95834
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/11/2022; 04/27/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/20/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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® VOLUMA¿ XC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female