MAUDE Adverse Event Report: ALLERGAN JUVEDERM ULTRA PLUS XC TSK US

Catalog Number 94155

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

Patient Problems Ecchymosis (1818); Herpes (1898); Pain (1994); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 12/04/2014

Event Type  Injury  

Event Description

Patient reported they developed a "cold sore" or "(b)(6)", "bruising", "major pain" and "lumpiness" after injection in the nasolabial folds with 2 syringes of juvederm ultra plus xc.Patient also stated the "lumpiness" is at the "side of the chin and in the lip area.The events were noticed the day after injection.Four days after injection, the patient was treated with valtrex and topical steroids; three days later, patient was also treated with "antibiotics".Symptoms have improved, but are ongoing.This is the same event and the same patient reported under mdr id#3005113652-2014-00782 (b)(4).This mdr is being submitted for the second suspect product.Juvederm ultra plus sx, also a device manufactured by allergan.

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of "cold sore" or "(b)(6)", "bruising", "major pain", and "lumpiness" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• Manufacturer (Section D): ALLERGAN; pringy ; FR
• Manufacturer Contact: krista alvarado ; 301 w. howard lane, suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4435760
• MDR Text Key: 5382277
• Report Number: 3005113652-2014-00785
• Device Sequence Number: 1
• Product Code: LHM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 94155
• Device Lot Number: H30LA40145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: SYNTHROID
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR