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

Catalog Number 95834

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

Patient Problems Inflammation (1932); Pain (1994); Skin Inflammation (2443)

Event Date 11/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 ¿small blisters on the upper lip¿, ¿pain or tenderness¿, ¿lumps (which were warm) in the upper lip¿, ¿lumps could be seen as white nodules under the skin¿, ¿mild bleeding during injection¿, ¿burning sensation after developing the blisters¿, ¿inflammation/irritation implantation site¿, and ¿sensation increase/decrease¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: 4.Warnings ¿ injection site responses consist mainly of short-term inflammatory symptoms starting early after treatment and lasting = 30 days.Refer to the adverse events section for details.5.Precautions ¿ as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.¿ patients may experience late onset adverse events with use of dermal fillers, including juvéderm volbella® xc.Refer to adverse events section for details.6.Adverse events table 1.Injection site responses by severity after initial treatment occurring in > 5% of treated subjects.Possible treatment site responses include: swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching, and dryness.C.Postmarket surveillance the following reported adverse events were received from postmarket surveillance on the use of juvéderm volbella® xc for lip augmentation outside the united states and were not observed in the clinical study.These adverse events, with a frequency of 5 events or more, are listed in order of prevalence: inflammatory reaction, loss/lack of correction, hematoma, allergic reaction, infection, paresthesia, herpes, migration, angioedema, and necrosis.In many cases the symptoms resolved without any treatment.Reported treatments included the use of (in alphabetical order): analgesics, antibiotics, antihistamines, anti-viral, arnica, drainage, hyaluronidase, ice, laser treatment, massage, nsaids, steroids, and warm compress.Outcomes for these reported events ranged from resolved to ongoing at the time of last contact.

Event Description

Healthcare professional reported the patient was injected in the perioral area with one syringe of juvéderm volbella® xc.A month later the patient returned and received restylane lyft in the midface.Three days later the patient formed small blisters on the upper lip and began taking valtrex 2000 mg bid x 1, refill x 2.Three days after that the patient came into the office for a visual follow up, and stated there was no more pain or tenderness, but felt lumps (which were warm) in the upper lip.Lumps were white nodules under the skin.It was noted that patient had mild bleeding during injection.Patient also reported a burning sensation after developing the blisters.The patient received hylenex 0.05 cc into three areas, for a total of 0.15 cc and a medrol dosepak.Two weeks later hylenex was injected again, two days later another injection of hylenex was injection.Patient has a history of allergies to penicillin, has had dermal fillers in the past, a history of fever blisters, and was taking effexor, wellbutrin, lamotrigine, and trazadone concomitantly.Patient commented that it was getting better, but not completely resolved.

Event Description

Additional information: date of symptom resolution is four and a half months after injection.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7172599
• MDR Text Key: 96664313
• Report Number: 3005113652-2018-00006
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628032460
• UDI-Public: 10888628032460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2018
• Device Catalogue Number: 95834
• Device Lot Number: V15LA70027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EFFEXOR, WELLBUTRIN, LAMOTRIGINE, AND TRAZADONE
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR