MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

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.The event of throat infection, deemed not device related is considered an unexpected adverse drug experience.

Event Description

Healthcare professional (hcp) reported patient was injected 1ml of juvéderm® voluma¿ xc to the t1's and 1ml of juvéderm® volift¿ into both cheeks.About two months later, patient reported after the a throat infection, a late inflammatory reaction developed in the form of raised papules on the skin surface in each area on the cheeks.There were absolutely no papules after the procedure.The condition regressed with steroids.It relapsed when the steroids were stopped.The patient did not request hyaluronidase.Symptoms are on going.This is the same event and the same patient reported under abbvie complaint (b)(4).This mdr is being submitted for the suspect product, juvéderm¿ voluma¿ xc.

Event Description

Healthcare professional (hcp) reported patient was injected 1ml of juvéderm® voluma¿ xc to the t1's and 1ml of juvéderm® volift¿ into both cheeks.About two months later, patient reported after the a throat infection, a late inflammatory reaction developed in the form of raised papules on the skin surface in each area on the cheeks.There were absolutely no papules after the procedure.The condition regressed with steroids.It relapsed when the steroids were stopped.The patient did not request hyaluronidase.Symptoms are on going.This is the same event and the same patient reported under abbvie complaint (b)(4).This mdr is being submitted for the suspect product, juvéderm¿ voluma¿ xc.

Manufacturer Narrative

Previous emdr submission noted the event deemed as an unexpected adverse drug experience.However, upon further review, the device does not meet reporting requirements aligned with us combination product reporting for medical devices.

• Brand Name: JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN)
• 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; zone artisanale de pre-mairy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18842332
• MDR Text Key: 336956411
• Report Number: 3005113652-2024-00155
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: TU
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA-ADDITIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 49 YR
• Patient Sex: Female