MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151ED

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

Patient Problems Abscess (1690); Cyst(s) (1800); Skin Irritation (2076)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. 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 Description

Healthcare professional reported injecting a patient with a juvederm voluma with lidocaine in the cheeks (ck1, ck2). Patient returned to the clinic and notified the clinic that they had the filler surgically removed, surgical drainage, about 7 months post-injection due a to pain and a palpable cyst 6 weeks prior from the left side cheek. Six weeks prior to that, the patient had developed symptoms of pain and an abscess on the left side. Patient had been told it was due to delayed onset nodule. Patient had not come back to the clinic earlier as they were embarrassed. When the patient was reviewed, it was found that the patient had an abscess drained via incision and drainage on the left side medial to orbicularis occuli. The product had not been injected in that area. Patient also noted sporadically having flare ups under the orbicularis occuli on the right side that were painful to the touch. There were no flare ups at the time of the review. Patient was given some healite yellow. The patient's face and hands were dry and flaky at appearance. Hyalase has been used on the right side. The left side abscess has resolved. ¿on the right side of the face ongoing¿. Patient additionally noted that they suffer with sinus on occasion.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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 ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 9167054
• MDR Text Key: 169824096
• Report Number: 3005113652-2019-00701
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 94151ED
• Device Lot Number: VB20A80443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/08/2019 Patient Sequence Number: 1