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.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.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 consulted a dermatologist who performed an incisional biopsy 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.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.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 event is ongoing.This is the same event and the same patient reported under mfr report # 3005113652-2021-00410 (b)(4), mfr report # 3005113652-2021-00411 (b)(4), mfr report #3005113652-2021-00409 (b)(4), and mfr report #3005113652-2021-00408 (b)(4).This mdr is being submitted for the fifth 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 74370 ; FR 74370
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; austin, TX ; 8479375615
• MDR Report Key: 11820819
• MDR Text Key: 251194494
• Report Number: 3005113652-2021-00412
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA90233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR