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	Unspecified Infection (1930); Respiratory Tract Infection (2420)
Date of Event	07/16/2019
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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: 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.The events of "otitis media, sinusitis" and "pneumonia" are deemed not related to the device and are considered an unexpected adverse drug experience.
Event or Problem Description
Health professional reported injecting a patient in the left tear trough with 0.2 ml of juvéderm volbella® xc.Five months later, the patient was injected bilaterally in the tear troughs with 0.4 ml of juvéderm volbella® xc.Six months later, the patient presented with ¿induration and fullness¿ which further specified as "firm, non-tender, mildly erythematous, madly edematous area" in the injection sites.That day, the patient was treated with prednisone that they did not take and instead went to see their primary care physician.The next day, the patient was treated with a hyaluronidase/5fu/lidocaine blend.One week later, the patient reported that they were diagnosed with a "otitis media and sinusitis," deemed not related to the injection, and was treated with another hyaluronidase/5fu/lidocaine blend.One week later, the patient reported that they had "pneumonia," deemed not related to the injection.The patient was treated with another hyaluronidase/5fu/lidocaine blend.The events resolved, with a "lesion" being reported as resolved.This is the same event and the same patient reported under mdr id# 3005113652-2020-00671 (allergan complaint # (b)(4)).This mdr is being submitted for the first injection of suspect product, juvéderm volbella® xc.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Health professional reported injecting a patient in the left tear trough with 0.2 ml of juvéderm volbella® xc.Five months later, the patient was injected bilaterally in the tear troughs with 0.4 ml of juvéderm volbella® xc.Six months later, the patient presented with ¿induration and fullness¿ which further specified as "firm, non-tender, mildly erythematous, madly edematous area" in the injection sites.That day, the patient was treated with prednisone that they did not take and instead went to see their primary care physician.The next day, the patient was treated with a hyaluronidase/5fu/lidocaine blend.One week later, the patient reported that they were diagnosed with a "otitis media and sinusitis," deemed not related to the injection, and was treated with another hyaluronidase/5fu/lidocaine blend.One week later, the patient reported that they had "pneumonia," deemed not related to the injection.The patient was treated with another hyaluronidase/5fu/lidocaine blend.The events resolved, with a "lesion" being reported as resolved.This is the same event and the same patient reported under mdr id# 3005113652-2020-00671 (allergan complaint # (b)(4)).This mdr is being submitted for the first injection of 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 74370 ; FR 74370
• MDR Report Key: 10795154
• Report Number: 3005113652-2020-00642
• Device Sequence Number: 16945057
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 04/02/2019
• Device Model Number: 95834
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR