MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96656JR

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

Patient Problems Pneumonia (2011); Viral Infection (2248); Nodule (4551)

Event Date 01/15/2022

Event Type  Injury  

Manufacturer Narrative

The event of inflammatory nodule is a known potential adverse event addressed in the product labeling.The event of ¿covid pneumonia¿ deemed not device related is considered an unexpected adverse drug experience.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.

Event Description

Healthcare professional reported that a patient was injected in the lips with 1 ml of juvéderm® volift® retouch and 53 units of botox in glabella, forehead and crows feet.Approximately two months later, patient started to have lip symptoms but did not contact the office until a month later.Patient contacted the office reporting they have little nodules over top lip and inner lips as well.It was tender to touch with pain score of 2/10 that relieves with solpadeine.A few days prior to onset of lip symptoms, patient had covid pneumonia, deemed not related to the device, and was as very sick including high grade fever and sob.Patient had consolidation on cxr but did not require oxygen.Patient was put on oral augmentin at home and recovered three to four weeks later.As for the inflammatory nodules, patient was treated with paracetamol 1g tds/prn (po) x 1/52.Clarithromycin 500mg bd (po) x 1/52.Oral prednisolone 60/50/40/30/20/10/10/5/5/5mg (tapering for 10days).Three days after treatment, patient reported the swellings are resolving with no tenderness and feeling much better.

Manufacturer Narrative

Continued d.11.Concomitant therapies: post-treatment was noted as arnica cream.

Event Description

Healthcare professional reported that a patient was injected in the lips with 1 ml of juvéderm® volift® retouch and 53 units of botox in glabella, forehead and crows feet.Approximately two months later, patient started to have lip symptoms but did not contact the office until a month later.Patient contacted the office reporting they have little nodules over top lip and inner lips as well.It was tender to touch with pain score of 2/10 that relieves with solpadeine.A few days prior to onset of lip symptoms, patient had covid pneumonia, deemed not related to the device, and was as very sick including high grade fever and sob.Patient had consolidation on cxr but did not require oxygen.Patient was put on oral augmentin at home and recovered three to four weeks later.As for the inflammatory nodules, patient was treated with paracetamol 1g tds/prn (po) x 1/52.Clarithromycin 500mg bd (po) x 1/52.Oral prednisolone 60/50/40/30/20/10/10/5/5/5mg (tapering for 10days).Three days after treatment, patient reported the swellings are resolving with no tenderness and feeling much better.

• Brand Name: JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1
• 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: 13664110
• MDR Text Key: 286579413
• Report Number: 3005113652-2022-00122
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 08435219540078
• UDI-Public: 8435219540078
• Combination Product (y/n): Y
• Reporter Country Code: EI
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 96656JR
• Device Lot Number: V17LB00750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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: CLINISEPT SOLUTION, NUMBING CREAM; PRETREATED WITH CLINISEPT SOLUTION.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White