MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155

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

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 01/02/2020

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.A review of the device history record has been completed.No deviations or non-conformances were observed.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient reported they were injected with juvéderm® ultra plus xc and experienced ¿redness,¿ the area was ¿warm to the touch,¿ and was ¿swollen on the upper left cheek¿ 2 weeks later at the injection site.Patient was treated with ciprofloxacin and symptoms improved.Patient was injected a second time about a month later in the jaw lines bilaterally with an unspecified type of juvéderm® product and, once again, ¿developed redness and warm to the touch and swollen on the upper left cheek, this time not in the injected area, but at the previous area where [they] experienced the adverse events¿ 2 days later.Three days after the second injection, patient was treated with a z-pack.Three days later, area was dissolved with hyalase to ¿get rid of inflammation¿ and symptoms resolved.This is the same event and the same patient reported under mdr id # 3005113652-2020-00046 (allergan (b)(4)).This mdr is being submitted for juvéderm® ultra plus xc.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 9722803
• MDR Text Key: 190305222
• Report Number: 3005113652-2020-00045
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: 94155
• Device Lot Number: H30LA90427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR