MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (1 ML COC); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154ED

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

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

Event Date 02/29/2020

Event Type  Injury  

Manufacturer Narrative

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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional (hcp) reported that the patient was pre-treated with nummit® and chlorhexidine.The hcp injected the patient in the lips, lp1 and lp8, with 0.3 ml of juvéderm ultra® xc.The hcp used 0.025ml linear threads across the lips as the patient wanted very subtle result and the hcp knew the patient ¿usually swelled considerably.¿ following the injection, the hcp noted swelling in the right side of the top lip.However, capillary refill time (crt) was normal and no blanching or pain was at the site.Furthermore, the swelling had reduced by the end of the injection.The hcp ¿massaged the product well thereafter¿ and monitored the patient.On the following day, the patient reported ¿some bruising¿ on the right side of the upper lip; the patient also reported to feel fine.Pictures were requested by the hcp who noticed an area of pallor above the top right lip at vermillion border and the nasolabial fold (nlf).Patient was advised to go to one of the clinics to be reviewed by an hcp.The patient was treated with hyalase® sanofi diluted in 5 ml lidocaine 1% to the lips, perioral area, and nlfs, after a vascular occlusion was diagnosed.The hcp felt the crt had normalized and scheduled review for the following morning.The following morning, there was ongoing concern that crt was sluggish.Another senior hcp was consulted.The patient was treated again with hyalase® diluted in 5 ml lidocaine 1% to the lips, perioral area, nlfs, and both sides of the nose.The injector assessed the progress and felt that the crt was still sluggish.The injector treated the patient with hyalase® diluted in 5 ml lidocaine 1% to the lips, perioral area, nlfs, and both sides of the nose, along the distribution of the angular and facial artery on the right and left side.Gtn paste was applied and patient was put under led light.The injector ¿started antibiotics to cover infection.¿ crt was much improved but there was bruising from the hyalase® injections.On the afternoon, the patient had slight pallor extending up the right and left nlf.Crt was slightly sluggish on the right.Hyalase® diluted in 3ml normal saline was administered again to the nlfs and up both sides of nose; after the treatment crt was less than 1 second throughout.The treatment was reported as necessary to hasten resolution and prevent permanent damage.The patient was reviewed on the following morning; crt remained normal and bruising and swelling were much improved.Patient was scheduled for twice daily reviews and led treatments.At day 5 review following the adverse event, bruising was almost completely resolved, swelling was completely resolved, and patient felt well.The patient didn¿t feel the need for further reviews.

Event Description

Healthcare professional (hcp) reported that the patient was pre-treated with nummit® and chlorhexidine.The hcp injected the patient in the lips, lp1 and lp8, with 0.3 ml of juvéderm ultra® xc.The hcp used 0.025ml linear threads across the lips as the patient wanted very subtle result and the hcp knew the patient ¿usually swelled considerably.¿ following the injection, the hcp noted swelling in the right side of the top lip.However, capillary refill time (crt) was normal and no blanching or pain was at the site.Furthermore, the swelling had reduced by the end of the injection.The hcp ¿massaged the product well thereafter¿ and monitored the patient.On the following day, the patient reported ¿some bruising¿ on the right side of the upper lip; the patient also reported to feel fine.Pictures were requested by the hcp who noticed an area of pallor above the top right lip at vermillion border and the nasolabial fold (nlf).Patient was advised to go to one of the clinics to be reviewed by an hcp.The patient was treated with hyalase® sanofi diluted in 5 ml lidocaine 1% to the lips, perioral area, and nlfs, after a vascular occlusion was diagnosed.The hcp felt the crt had normalized and scheduled review for the following morning.The following morning, there was ongoing concern that crt was sluggish.Another senior hcp was consulted.The patient was treated again with hyalase® diluted in 5 ml lidocaine 1% to the lips, perioral area, nlfs, and both sides of the nose.The injector assessed the progress and felt that the crt was still sluggish.The injector treated the patient with hyalase® diluted in 5 ml lidocaine 1% to the lips, perioral area, nlfs, and both sides of the nose, along the distribution of the angular and facial artery on the right and left side.Gtn paste was applied and patient was put under led light.The injector ¿started antibiotics to cover infection.¿ crt was much improved but there was bruising from the hyalase® injections.On the afternoon, the patient had slight pallor extending up the right and left nlf.Crt was slightly sluggish on the right.Hyalase® diluted in 3ml normal saline was administered again to the nlfs and up both sides of nose; after the treatment crt was less than 1 second throughout.The treatment was reported as necessary to hasten resolution and prevent permanent damage.The patient was reviewed on the following morning; crt remained normal and bruising and swelling were much improved.Patient was scheduled for twice daily reviews and led treatments.At day 5 review following the adverse event, bruising was almost completely resolved, swelling was completely resolved, and patient felt well.The patient didn¿t feel the need for further reviews.

Manufacturer Narrative

Additional data: h.6.Clarification to h6: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.

• Brand Name: JUVEDERM ULTRA XC (1 ML COC)
• 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: 9944208
• MDR Text Key: 190489398
• Report Number: 3005113652-2020-00198
• Device Sequence Number: 1
• Product Code: LMH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LA90529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUMMIT®, CHLORHEXIDINE.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR