MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

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

Patient Problem Swollen Lymph Nodes (2093)

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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported after self-injecting with juvéderm® ultra in the marionette lines, and nasolabial folds, it doesn¿t seem to last.The patient has been injecting the product for years, but now it just didn¿t seem to last.Injections take place in approximately 3-month intervals, and the injector believes they have developed ¿antibodies¿ because their lymph nodes were getting larger.It was noted that they have "few lymph node growth in jawline, some resolved, some still there".This is the same event and the same patient reported under mdr id # 3005113652-2020-00266 (b)(4), mdr id # 3005113652-2020-00268 (b)(4), mdr id # 3005113652-2020-00269 (b)(4), and mdr id # 3005113652-2020-00270 (b)(4).This mdr is being submitted for juvéderm® ultra.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (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: 10103360
• MDR Text Key: 193051765
• Report Number: 3005113652-2020-00267
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention