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 01/26/2024

Event Type  Injury  

Event Description

Healthcare professional reported injecting a patient with 2 syringes of skinvive¿ by juvéderm® into cheeks, patient experienced an occlusion on their left cheek above the jawline.Patient was treated with 3 vials of hylenex.Symptom has been resolved.

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.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.

Manufacturer Narrative

Additional, changed, and/or corrected data: a2, a6, b7, h8.

Event Description

Healthcare professional reported injecting a patient with 2 syringes of skinvive¿ by juvéderm® into cheeks, patient experienced an occlusion on their left cheek above the jawline.Patient was treated with 3 vials of hylenex.Symptom has been resolved.

• 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): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18730588
• MDR Text Key: 335703371
• Report Number: 3005113652-2024-00119
• Device Sequence Number: 1
• Product Code: LMH
• 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
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 98307
• Device Lot Number: 1000524565
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White