MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 95661

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

Patient Problems Cyst(s) (1800); Inflammation (1932); Skin Irritation (2076)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events of cyst, nodule, warm, cystic-like area, bruising, swelling, and redness are physiological complications 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 initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient in the oral commissures and marionette lines with 2 syringes of juvéderm vollure¿ xc.The evening of the injection, the patient experienced ¿bruising and swelling.¿ the patient ¿developed a nodule in the left commissures and area was warm to touch¿ and a "cyst, cystic-like area." twelve days after injection, the patient was treated with augmentin 125 mg bid po.The patient was given clindamycin (when not responding to augmentin) 3 days later.One week later, a culture, i & d, and a wick were performed with the results being negative.Four days later, the patient was given cipro x 10 days and had an i & d again and was noted as ¿very full of puss.¿ a ct scan was performed that resulted in negative 9 days later.The following day, clindamycin was restarted when ¿redness returns.¿ the patient was given flagyl and levaquin 2 days later.The next day, the patient was hospitalized and given vancomycin 1000 x 3 bags.The patient was discharged the next day with a prescription for doxycycline 100 mg x 2/daily x 7 days, which were completed.The next day, the patient had a third i & d with stitches.The patient was referred to an id physician 2 days later.Five days later, the sutures were removed and was ¿looking better.¿ eleven days later, the ¿swelling returned¿ and the patient was restarted on doxycycline.Two days later, a culture was attempted but there was not enough drainage.A fourth i & d was performed as well as an afb culture the next day.Symptoms are ongoing.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• 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: 8425249
• MDR Text Key: 138946852
• Report Number: 3005113652-2019-00203
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: 10888628034471
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: 95661
• Device Lot Number: V17LA80572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2018
• 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: RENTIN-A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR