MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94506KO

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of vascular occlusion is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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

Healthcare professional reported that a patient was pretreated with matu cream and betadine disinfection and then injected with 0.5cc of juvéderm® voluma® with lidocaine in the right nasolabial folds.Approximately 2 to 3 hours after the injection "facial art occlusion compensation appeared at the corresponding area" at the "right nasolabial fold and side of nose" and patient was treated with a hyaluronidase injection.Patient was also prescribed antibiotics and anti-inflammatory drugs on this date.Symptoms are ongoing.It was also noted this injection was a reuse of the syringe.

Event Description

Healthcare professional reported that a patient was pretreated with matu cream and betadine disinfection and then injected with 0.5cc of juvéderm® voluma® with lidocaine in the right nasolabial folds.Approximately 2 to 3 hours after the injection "facial art occlusion compensation appeared at the corresponding area" at the "right nasolabial fold and side of nose" and patient was treated with a hyaluronidase injection.Patient was also prescribed antibiotics and anti-inflammatory drugs on this date.Symptoms are ongoing.It was also noted this injection was a reuse of the syringe.

Manufacturer Narrative

Clarification: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of vascular occlusion is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.

Manufacturer Narrative

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

Event Description

Healthcare professional reported that a patient was pretreated with matu cream and betadine disinfection and then injected with 0.5cc of juvéderm® voluma® with lidocaine in the right nasolabial folds.Approximately 2 to 3 hours after the injection "facial art occlusion compensation appeared at the corresponding area" at the "right nasolabial fold and side of nose" and patient was treated with a hyaluronidase injection.Patient was also prescribed antibiotics and anti-inflammatory drugs on this date.Symptoms are ongoing.It was also noted this injection was a reuse of the syringe.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1 ML
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13514225
• MDR Text Key: 285536612
• Report Number: 3005113652-2022-00062
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Catalogue Number: 94506KO
• Device Lot Number: VB20B00535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MATU CREAM AND BETADINE DISINFECTION
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG