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

Catalog Number UNK JUVEDERM ULTRA XC/LIDO

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

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Inflammation (2443)

Event Date 01/14/2019

Event Type  Injury  

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 ¿bruising, swelling, itchiness and blisters on just one side of the injected area" and ¿infection¿ are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient reported being injected in the nasolabial folds with one syringe of juvéderm® ultra xc.The patient reported "bruising, swelling, itchiness and blisters on just one side of the injected area¿ at an unspecified time later.At an unspecified time later, the patient self-medicated with valtrex because they believed it was a cold sore.Four days after injection, the patient was diagnosed with ¿infection¿ and administered keflex and ¿suggested to take valtrex¿ as well.A test was administered at an unspecified time to verify it the issue was bacterial or viral, but both came up negative.Symptoms ongoing.

• Brand Name: JUVEDERM ULTRA XC/LIDO (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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8364302
• MDR Text Key: 136978125
• Report Number: 3005113652-2019-00168
• 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: consumer
• Type of Report: Initial
• Report Date: 02/22/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA XC/LIDO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR