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

Catalog Number 94731RX

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

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Skin Irritation (2076)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

Further information 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.A review of the device history record has been completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional (hcp) reports injecting a patient in the lips with juvéderm® volbella¿ with lidocaine and again about a month later with another syringe of juvéderm® volbella¿ with lidocaine.Nine months after the first injection, ¿patient has had labial and perilabial edema, which is very hard and progressive.They were small nodules at the beginning and after two weeks, very diffuse edema.¿ hcp prescribed prednisone and loratadine.Patient improved after the first days of orally corticosteroids.Hyaluronidase injected with even greater improvement, but lumps persisted and were much smaller.A biopsy was performed and showed a foreign body granulomatous reaction.3 weeks post symptom onset, patient woke up with swelling again (lip and perilabial edema).Patient reports they had intense sweating.After reviewing several articles, hcp was unsure whether to treat granuloma alone (intralesional corticosteroid and minocycline orally) or biofilm empiric, with cipro and clarithromycin for six weeks.Hcp discussed with a pathologist, whose main hypothesis is foreign body granulomatous reaction, not infection.The granulomas are well formed.Minocycline was started and the patient has already reported improvement but has nodules in the lips (the nodules are individualized, but several, arranged in a "pearl necklace", following the application path with cannula).The doctor has requested general exams, but still has no results.It is unknown if symptoms have resolved.This is the same event and the same patient reported under mdr id 3005113652-2019-00766 (allergan pr (b)(4)).This is the first mdr submitted for the first injection of juvéderm® volbella¿ with lidocaine.

• Brand Name: VOLBELLA 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): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 9469158
• MDR Text Key: 185513465
• Report Number: 3005113652-2019-00765
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA80063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR