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

Catalog Number 96637RX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cytomegalovirus (CMV) Infection (2220)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "herpes" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient in the lips and nasolabial folds with 1.5 ml of juvéderm® voluma¿ with lidocaine.The syringe had a plunger that was ¿loosening¿ when performing suction and ¿could not perform aspiration puncture.¿ this was a reuse of the syringe.Two days later, the patient experienced ¿herpes¿ in the lips.The patient was treated with acyclovir 200 mg every 4 hours, orally, 5 days.The event resolved a week after onset.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional reported injecting a patient in the lips and nasolabial folds with 1.5 ml of juvéderm® voluma¿ with lidocaine.The syringe had a plunger that was ¿loosening¿ when performing suction and ¿could not perform aspiration puncture.¿ this was a reuse of the syringe.Two days later, the patient experienced ¿herpes¿ in the lips.The patient was treated with acyclovir 200 mg every 4 hours, orally, 5 days.The event resolved a week after onset.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12783113
• MDR Text Key: 280575339
• Report Number: 3005113652-2021-03402
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 96637RX
• Device Lot Number: VB20B01026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: LIDOCAINE, ALCOHOL 70%
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female