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 Necrosis (1971); Vascular System (Circulation), Impaired (2572)

Event Date 05/06/2020

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 reports that a patient was injected with 1 ml juvéderm¿ volift¿ with lidocaine.Patient informed that there was no adverse event after this injection.Approximately 60 days later, an additional 2 ml of juvéderm¿ volift¿ with lidocaine was applied.Product injected into the lips.Patient developed vascular occlusion and necrosis.Change in color and pain noticed between 8-10 hours after the injection, but patient went to bed to sleep.The next morning, patient contacted the physician and suspected a vascular event based upon photos seen on the internet.Physician observed lightness or marbling skin in the territories irrigated by the superior labial, inferior labial, lateral of nose and even the angular arteries, the mucosa was untouched at the time.Ulcerations observed at the level of the lower lip mucosa via pictures previously taken by patient.Patient states ¿it didn't hurt but it has a weird feeling." event was considered a ¿tissue integrity threat." hyaluronidase provided after 2 days.Aspirin, warm compresses,cephalexin, sildenafil 25 mg and an injectable corticosteroid also provided.Symptoms resolved 2.5 weeks post onset.This is the same event and the same patient reported under mdr id# 3005113652-2020-00305 (allergan complaint #(b)(4)).This mdr is being submitted for the second injection of juvéderm¿ volift¿ with lidocaine.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reports that a patient was injected with 1 ml juvéderm¿ volift¿ with lidocaine.Patient informed that there was no adverse event after this injection.Approximately 60 days later, an additional 2 ml of juvéderm¿ volift¿ with lidocaine was applied.Product injected into the lips.Patient developed vascular occlusion and necrosis.Change in color and pain noticed between 8-10 hours after the injection, but patient went to bed to sleep.The next morning, patient contacted the physician and suspected a vascular event based upon photos seen on the internet.Physician observed lightness or marbling skin in the territories irrigated by the superior labial, inferior labial, lateral of nose and even the angular arteries, the mucosa was untouched at the time.Ulcerations observed at the level of the lower lip mucosa via pictures previously taken by patient.Patient states ¿it didn't hurt but it has a weird feeling." event was considered a ¿tissue integrity threat." hyaluronidase provided after 2 days.Aspirin, warm compresses,cephalexin, sildenafil 25 mg and an injectable corticosteroid also provided.Symptoms resolved 2.5 weeks post onset.This is the same event and the same patient reported under mdr id# 3005113652-2020-00305 (allergan complaint #(b)(4)).This mdr is being submitted for the second injection of 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
• MDR Report Key: 10158059
• MDR Text Key: 195256574
• Report Number: 3005113652-2020-00306
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA90497
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR