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

Catalog Number 96637JR

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

Patient Problem Abscess (1690)

Event Date 02/01/2022

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 abscess 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 (hcp) reported patient was injected with 3 syringes of juvéderm® voluma¿ with lidocaine and experienced early inflammation with pus drainage.Patient was prescribed antibiotics.Symptoms improved, but the induration persisted and the inflammation recurred.Patient was prescribed corticoids and varidasa.One week later, patient was prescribed antibiotics again.Patient developed a zone with apparent purulent collection that hasn't been drained.This is the same event and the same patient reported under mdr id# 3005113652-2022-00239 (allergan complaint #(b)(4)).This mdr is being submitted for the suspect product, juvéderm® voluma¿ with lidocaine with lot number vb20b10414.

Manufacturer Narrative

Further information from the reporter 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 completed.No deviations or non-conformances noted.

Event Description

Healthcare professional (hcp) reported patient was injected with 3 syringes of juvéderm® voluma¿ with lidocaine and experienced early inflammation with pus drainage.Patient was prescribed antibiotics.Symptoms improved, but the induration persisted and the inflammation recurred.Patient was prescribed corticoids and varidasa.One week later, patient was prescribed antibiotics again.Patient developed a zone with apparent purulent collection that hasn't been drained.This is the same event and the same patient reported under mdr id# 3005113652-2022-00239 (allergan complaint #pr (b)(4).This mdr is being submitted for the suspect product, juvéderm® voluma¿ with lidocaine with lot number vb20b10414.

Event Description

Additional information noted a depression area where the abscess was but was corrected using hyaluronic acid.The event resolved approximately three months and a half after onset.

• Brand Name: JUVÉDERM 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: 14213047
• MDR Text Key: 290117442
• Report Number: 3005113652-2022-00238
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 05016007208092
• UDI-Public: 5016007208092
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 96637JR
• Device Lot Number: VB20B10414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 06/01/2022; 07/01/2022
• Supplement Dates FDA Received: 06/09/2022; 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female