MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (2 X 0.4 ML); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	93899
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Edema (1820); Skin Irritation (2076)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported events of "lymphatic swelling", "full face", "under eyes swelling", and "nodules" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter 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 or Problem Description
Healthcare professional reported to have injected a patient in the cheeks and temple with 2 syringes of juvéderm ultra¿ xc.Over a month later, the patient experienced a reaction; the patient initially experienced lymphatic swelling, then full face and under eyes swelling, and nodules in the right cheek.The healthcare professional further reported that on the date of onset the patient had some swelling under the eyes and the patient was told to massage.The swelling continued, so patient was told to massage under the eye.The patient was then given antihistamines, hydrochlorothiazide, and doxy 100mg bid.About 3 weeks later, the patient was not better.There were visible nodules on the right cheek.Patient was injected with vitrase®.About a week later, the nodules were still present, so the patient was injected with hylenex and put on steroids.The swelling got better and the nodules smaller.The steroid was lowered.The patient was additionally treated with prednisone.The symptoms resolved almost 3 months after the date of onset.This is the same event and the same patient reported under mdr id # 3005113652-2019-00193 (allergan complaint # (b)(4)).This is the first mdr submitted for the first lot number of suspect product, juvéderm ultra¿ xc.

• Brand Name: JUVEDERM ULTRA XC (2 X 0.4 ML)
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• MDR Report Key: 8409732
• Report Number: 3005113652-2019-00192
• Device Sequence Number: 10867599
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: 30888628000074
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2019
• Device Catalogue Number: 93899
• Device Lot Number: H24LA80003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 41 YR