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

Catalog Number 94703RX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 03/10/2021

Event Type  Injury  

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.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.

Event Description

Healthcare professional (hcp) reported that the patient was injected in the lips with juvéderm® volift¿ with lidocaine with adequate initial evolution, little inflammation and satisfaction of size and shape.Over 9 months later patient noticed a formation of pimple on the lower lip mucosa on the right side, which increased in size, until patient noticed a violent accumulation.Patient attending consultation for mucosa injuries of the lower lip for several weeks with inflammation and associated pain.Patient consulted a dermatologist who performed an incisional biopsy (resection of the nodular injury was performed in the mucosa of lower lip on the left side) that reported granulomatous dermatitis secondary to the presence of external material.Study material was sent to immunohistochemical.Treatment with oral antibiotic and anti-inflammatory were given.¿presents scar in mucosa of lower lip with lower nodular injury of approximately 6 mm, without signs of overinfection¿ was noted during examination.Hcp assessed and found ¿an inflammatory nodule with an accumulation of yellowish material seen through the mucosa of the lower lip on the right side, not observed from the outside.It is also observed that the periodontal area is demarcated (diagnosis of bruxism).Asepsis and antisepsis, application of 2% lidocaine, little purulent material is extracted, observing a decrease in nodulation.Foreign body granuloma of skin and subcutaneous tissue was noted as diagnosis.Injected 3u of hyaluronidase with which the nodulation decreases remarkably.On the following day patient reported to feel better.2 days later the granuloma was observed smaller in size.3u hyaluronidase injected with good response.The nodule is reduced following application of hyaluronidase, but no more than 8 days pass by and it reappears.It is smaller in size.The symptom has improved but not resolved.This is the same event and the same patient reported under emdr-00457 (allergan complaint # (b)(4)), emdr-00760 (allergan complaint # (b)(4)), emdr-00761 (allergan complaint # (b)(4)), and mfr report # 3005113652-2021-00408, emdr-00763 (allergan complaint # (b)(4)).This emdr is being submitted for the second suspect product, juvéderm® volift¿ with lidocaine.

• Brand Name: VOLIFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy ; FR
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; austin, TX ; 8479375615
• MDR Report Key: 11820671
• MDR Text Key: 265210946
• Report Number: 3005113652-2021-00409
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA80198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR