MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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

Health professional reported that a patient was injected in the lips with one syringe of juvéderm vollure¿ xc.The patient experienced a ¿vascular occlusion¿ that day at the injection site.The next day, the patient was treated with 20 units of hylenex by the injector.Treatment was stopped because "the patient was crying, and it was very painful." another physician then injected the patient with an additional 300 units of hylenex and advised the patient to do over 2 hours of massage and apply a warm compress.The following morning, the patient was treated with an additional 700 units of hylenex, after which ¿blisters¿ began to form.The patient was again advised to apply warm compress and clean the wound with puracyn 3 times a day.The patient was prescribed valacyclovir, sildenafil, z-pak, medrol dosepak, and was recommended hyperbaric chamber daily for 5 days.The patient returned to the injector's office 10 days after onset and "has recovered.".

Manufacturer Narrative

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

Event Description

Health professional reported that a patient was injected in the lips with one syringe of juvéderm vollure¿ xc.The patient experienced a ¿vascular occlusion¿ that day at the injection site.The next day, the patient was treated with 20 units of hylenex by the injector.Treatment was stopped because "the patient was crying, and it was very painful." another physician then injected the patient with an additional 300 units of hylenex and advised the patient to do over 2 hours of massage and apply a warm compress.The following morning, the patient was treated with an additional 700 units of hylenex, after which ¿blisters¿ began to form.The patient was again advised to apply warm compress and clean the wound with puracyn 3 times a day.The patient was prescribed valacyclovir, sildenafil, z-pak, medrol dosepak, and was recommended hyperbaric chamber daily for 5 days.The patient returned to the injector's office 10 days after onset and "has recovered.".

Manufacturer Narrative

Additional, changed, and/or corrected data: b.5.

Event Description

Additionally, the health professional reported that they noted the area had turned ¿bluish¿ and initially believed the event to be a ¿bruise.¿ the area was massaged and treated with ice.Three days later, the patient received the 100 units of hylenex from a different health professional and was prescribed aspirin, valtrex, and keflex and was sent to receive hyperbaric oxygen.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 10410180
• MDR Text Key: 203110499
• Report Number: 3005113652-2020-00451
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

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 Expiration Date: 09/03/2021
• Device Catalogue Number: 95661
• Device Lot Number: V17LA90536
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 02/12/2021
• Supplement Dates FDA Received: 09/28/2020; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR