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 Problems Inflammation (1932); Skin Irritation (2076)

Event Date 10/11/2020

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.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 reported a patient was injected with juvéderm® voluma¿ with lidocaine in the malar (ck1, ck2) and mentonian (c1) regions with 1ml of juvéderm® voluma¿ with lidocaine and on the upper lip and groove with 1ml of juvéderm® volift¿ with lidocaine.10 days post-op, patient developed edema on the left upper lip.There is evidence of hardening of the product in the patient's body.The patient is under clinical medical treatment for the dilution (with hyaluronidase) of the injected product and treatment for pain.Patient also developed edema in the c1 region and no edema in the malar regions.The next day, patient was treated with predsim 20mg/day plus alektos 20mg/days but ¿the hardening worsened.¿ 3 days later, the dosage for predsim was increased and started clavulin.4 days later, patient had hardened nodules in the corners of the mouth and on the upper lip, ¿as a late reaction, related to the immunogenicity of the product." a week later, patient went to another office for a 2nd opinion and was prescribed antibiotics and corticoid.An ultrasound was performed 3 days after seeing another physician.Ultrasound did not show any abscess.Hyaluronidase was applied.Approximately 3 weeks later, patient symptoms has not been resolved with improvement of the edema, but still with palpable nodules in the groove and edema in the upper left lip.Hyaluronidase infiltration was performed again with triancil and anesthetic in the upper lip, lower lip on the left, and right and left nasolabial groove.Treatment was noted as led performed for 1 hour a few times with infiltration of hyaluronidase, triancil and anesthetic in the upper and lower lip, left side.Approximately a week later, patient presented significant improvement of lip edema.However, event has not completely resolved.

• 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): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 11008952
• MDR Text Key: 221563261
• Report Number: 3005113652-2020-00786
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA90749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR