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

Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE

Device Problem Off-Label Use (1494)

Patient Problem Necrosis (1971)

Event Date 04/01/2020

Event Type  Injury  

Event Description

Healthcare professional reported a patient ordered juvéderm® voluma¿ over the internet and self-injected in the lips after viewing internet video tutorials.Following the injection, an adverse event of "persistent deformation of the lips for more than 20 months" was immediately noted.8 weeks following the injection, there was bruising and major oedema away from the injection site with "distension of the mucosa with persistent edema and loss of shape of the upper lip." patient also had social embarrassment after they performed the injection.Current state of the patient was noted no knowledge of the risks for "necrosis, cessation, deformations.".

Manufacturer Narrative

The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of necrosis is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information 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 reported a patient ordered juvéderm® voluma¿ over the internet and self-injected in the lips after viewing internet video tutuorials.Following the injection, an adverse event of "persistent deformation of the lips for more than 20 months" was immediately noted.8 weeks following the injection, there was bruising and major oedema away from the injection site with "distension of the mucosa with persistent edema and loss of shape of the upper lip." patient also had social embarassment after they perfomed the injection.Current state of the patient was noted no knowledge of the risks for "necrosis, cessation, deformations.".

Event Description

Additional details received noting that 1ml of product was injected and packaged needle was used.

• 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
• 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: 13793537
• MDR Text Key: 287352523
• Report Number: 3005113652-2022-00143
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK JUVEDERM VOLUMA-ADDITIVE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female