MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

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

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

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: birth control pill, and xanax®.Clarification to evaluation method codes: the filler was injected into the patient and is not accessible for return.The syringe was discarded.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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional (hcp) reported performing lip volumizing with 0.7 ml of juvéderm® ultra xc, after 10 minutes of topical numbing, when arterial blanch occurred to the left upper lip to columella extending in triangle shape to corner of mouth.Hcp immediately stopped injecting the upper lip line and obtained emergency kit and hylenex® for occlusion protocol.Patient denied pain due to numbing placed prior.Hcp immediately flooded upper left lip with hylenex® with some relief of blanch/ collateral circulation seen with slow cap refill <5.Warm packs were placed immediately while prepping second vial of hylenex® for installation to tissue.Patient denied complaint and remained with warm pack in place.Acetylsalicylic acid was given to the patient.Hylenex® placed to lip tissue again to flood area and cap refill <3.5 sec.Hylenex® placed to upper lip area again for flooding.Hcp and physician were monitoring cap refill continuously.Patient tolerated well.Cap refill <3 seconds.Hylenex® administered to upper lip with cap refill resolving immediately with last injections.Cap refill returned to normal <2 seconds and all tissue pink.Patient continued to apply warmth.All the blanching resolved and ¿all tissue pink viable¿.Ecchymosis/swelling noted to posterior lip as hylenex® was administered.Patient was monitored in office for another 30 minutes.Patient was told to go home and follow up with the office on the following morning.At discharge cap refill <2 seconds to all tissues above lip and in lip.Patient will follow up daily for possible reinjection of hylenex® and tissue viability checks.Patient was concomitantly injected with botox®.Patient was taking prozac®, birth control pill, and xanax®.Patient is still recovering from the ecchymosis.Swelling is also resolving.

Event Description

Healthcare professional (hcp) reported performing lip volumizing with 0.7 ml of juvéderm® ultra xc, after 10 minutes of topical numbing, when arterial blanch occurred to the left upper lip to columella extending in triangle shape to corner of mouth.Hcp immediately stopped injecting the upper lip line and obtained emergency kit and hylenex® for occlusion protocol.Patient denied pain due to numbing placed prior.Hcp immediately flooded upper left lip with hylenex® with some relief of blanch/ collateral circulation seen with slow cap refill <5.Warm packs were placed immediately while prepping second vial of hylenex® for installation to tissue.Patient denied complaint and remained with warm pack in place.Acetylsalicylic acid was given to the patient.Hylenex® placed to lip tissue again to flood area and cap refill <3.5 sec.Hylenex® placed to upper lip area again for flooding.Hcp and physician were monitoring cap refill continuously.Patient tolerated well.Cap refill <3 seconds.Hylenex® administered to upper lip with cap refill resolving immediately with last injections.Cap refill returned to normal <2 seconds and all tissue pink.Patient continued to apply warmth.All the blanching resolved and ¿all tissue pink viable¿.Ecchymosis/swelling noted to posterior lip as hylenex® was administered.Patient was monitored in office for another 30 minutes.Patient was told to go home and follow up with the office on the following morning.At discharge cap refill <2 seconds to all tissues above lip and in lip.Patient will follow up daily for possible reinjection of hylenex® and tissue viability checks.Patient was concomitantly injected with botox®.Patient was taking prozac®, birth control pill, and xanax®.Patient is still recovering from the ecchymosis.Swelling is also resolving.

Manufacturer Narrative

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

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 10509040
• MDR Text Key: 206178141
• Report Number: 3005113652-2020-00520
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOTOX®, TOPICAL NUMBING, PROZAC®.; BOTOX®, TOPICAL NUMBING, PROZAC®.
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR