MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

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

Patient Problems Edema (1820); Rash (2033); Vascular System (Circulation), Impaired (2572)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant therapies: juvéderm volbella® xc.(b)(4).Further information regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.The events of "vascular compromise," "swelling", "rash" and "extreme swelling in entire face" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.These are known adverse events addressed in the product labeling.

Event Description

Healthcare professional (hcp) reported injecting a patient with one syringe of juvéderm voluma® xc in the cheeks and half of a syringe of juvéderm volbella® xc in the lips.Hcp stated after injection, patient experienced "what appeared to be a vascular compromise" on the left side of the lower lip; patient was "treat" with hylenex.A few hours after the treatment with hylenex, patient reported "swelling" in the lips.¿ later in the day, hcp stated the patient reported another "vascular compromise" in the upper lip and was treated with hylenex again by a different injector.After that, the swelling of the lips went down.One day after injection, patient reported they are experiencing "extreme swelling in entire face," for which hcp directed patient to their primary care physician.Hcp also indicated, patient often experiences "rashes on the body and swelling for unknown reasons." upon further follow up, hcp then added that the issue has ¿been resolved pretty much, except for that [patient] said [they were] recently diagnosed with lyme disease.¿ this is the same event and the same patient reported under mdr id# 3005113652-2018-01752 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspect product, juvéderm voluma® xc.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Additional data: date of event.

Event Description

Healthcare professional reported that the symptoms resolved 4 days after the symptoms appeared.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 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
• MDR Report Key: 8174438
• MDR Text Key: 130671633
• Report Number: 3005113652-2018-01734
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEPTIDE INJECTIONS IN THE STOMACH; PEPTIDE INJECTIONS IN THE STOMACH
• Patient Outcome(s): Required Intervention