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

Catalog Number 98307

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional (hcp) reported patient was injected with 1 syringe of skinvive¿ by juvéderm per cheek, intradermally while aspirating at each injection site.Immediately post injection, bruise was observed on right cheek.Capillary refill less than 3 seconds.No discoloration other than a blue hematoma approximately 0.5cm in diameter.Capillary refill checked bilaterally after all injections were complete, approximately 45 minutes later, with no sign of vascular event nor pain.A couple hours post injection, patient noticed mottling on right cheek and decreased capillary refill.Blanching and livedo reticularis observed along the right lateral nose, nasolabial fold, and lateral to oral commissure.New hematoma observed on right cheek 4 cm inferior to the orbital rim, in line with lateral canthus.Patient was treated with firm massage, aspirin, heat pack, and 3 vials of hylenex.Blanching appeared to improve with capillary refill of about 3 seconds.The following morning, patient reported increased pain, increased blanching, and increased livedo reticularis and decreased capillary refill.Hcp suspects transverse facial artery was likely affected in the location where the initial hematoma occurred.Hcp assesses patient in person and notes capillary refill is delayed about 4 seconds along the majority of the right cheek.Treatment with heat, massage, 2ml of plain 2% lidocaine, and 9 vials of hylenex.Patient reported soreness and tenderness later that day.The following day, hcp notes slight mottling is observed along the lateral right side of nose and and below the cheekbone but covers less surface area than the day prior.Capillary refill is less than 3 seconds.Ultrasound performed and blow flow appeared the same as non-affected left side.Medtrol pack prescribed to help with inflammation, patient instructed to take ibuprofen for pain and swelling.Symptoms ongoing.

• Brand Name: SKINVIVE BY JUVEDERM 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18961910
• MDR Text Key: 338387221
• Report Number: 9617229-2024-04984
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: 10840228300066
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 98307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention