MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA 3/SMILE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swollen Lymph Nodes (2093)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event of "lymph node swelling" is considered an unexpected adverse drug experience.

Event Description

Patient reports 1.0 ml juvéderm ultra¿ 3 injection to the nasolabial fold.Upon waking up the next morning, "one side was fine, but the other side (left side) was swollen leading to the undereye.Patient described it as a lymph node swelling.Patient also stated that they felt pressure pain on the swelling and took some ibuprofen.Patient admitted to the hospital and treated with cortisone and antibiotics.

• Brand Name: JUVEDERM ULTRA 3/SMILE (VOLUME 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): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10697657
• MDR Text Key: 211901892
• Report Number: 3005113652-2020-00619
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA 3/SMILE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/19/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR