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

Catalog Number UNK VOLBELLA

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

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.The events of cyst, tumor, mucocele, and pain are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported events as follows: precautions: ¿ patients may experience late onset adverse events with use of dermal fillers, including juvéderm volbella® xc.Refer to adverse events section for details.Adverse events: per table 1: injection site responses by severity after initial treatment occurring in > 5% of treated subjects, possible injection site responses after injection with juvéderm volbella® xc include: swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness.Treatment-related aes after initial treatment (or touch-up treatment) occurring in = 5% of subjects included chapped lips, dizziness, dry lips, general physical condition abnormal, headache, lip disorder (lumps), lip injury, oral herpes, presyncope, wound, and injection site discoloration, discomfort, edema, erythema, exfoliation, hyperaesthesia, hypoaesthesia, laceration, nodule, papule, paraesthesia, pruritus, and reaction.

Event Description

Patient reported approximately one month after injection in the lips with one syringe of juvéderm volbella® xc they developed a "tumor, cyst or more like a mucocele" in the inner lower left lip that "kept getting larger and larger".An oral surgeon removed some of the product and it was sent for pathology.Results came back as "exogenous or foreign substance." patient still has a cyst next to where the product was taken out and the area is still painful.Patient might have another procedure to take out the scar tissue on the lip, but the oral surgeon wants to wait 3 or 4 months.Symptoms are ongoing at this time.Patient was taking levothyroxine at the time of injection.

• Brand Name: UNK VOLBELLA
• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 6836394
• MDR Text Key: 84314284
• Report Number: 3005113652-2017-00955
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 08/31/2017

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 Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR