MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA 3/SMILE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Nodule (4551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2023

Event Type  Injury  

Manufacturer Narrative

Continued h.6.Type of investigation code: b15, b17, b20.Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.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 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 that a patient was injected in nasogenian folders and lips with first injection of juvéderm® volbella¿ with lidocaine.2nd injection 9 days later, 3rd injection 13 days later and 4th injection 14 days later only in the lips.8 weeks later, patient experienced inflammation on lips and nodules and philtrum ridges.Patient was treated with ibuprofen.To prevent streptococcus infection, patient was prescribed ciprofloxacine and zamene.Symptoms ongoing / unresolved.This is the same event and the same patient reported under mdr id#: 3005113652-2023-00601 (abbvie complaint#: (b)(4), mdr id#: 3005113652-2023-00602 (abbvie complaint#: (b)(4), and mdr id#: 3005113652-2023-00604 (abbvie complaint#: (b)(4).This mdr is being submitted for the suspect product, 3rd injection with juvéderm® volbella¿ with lidocaine.

Event Description

Healthcare professional reported problem solved by removing juvéderm® volbella¿ with injected hyaluronidase in the nodules of the lips.A week ago, patient noticed the appearance of new nodules and induration at palpation in the treated zones with juvederm 3.The patient prefers for now not to remove the product as practically there is no aesthetic modification visible and was very happy with the obtained results so far".

Manufacturer Narrative

Additional, corrected, and/or changed data: b5, h6.

Event Description

Additional information clarify that patient was injected with a single syringe of juvéderm® volbella¿ (captured in mdr id# 3005113652-2023-00604 with abbvie complaint #(b)(4) that was used in its entirety by spreading it on the lips and ridges of the philtrum.This injection was noted to be juvéderm® ultra 3 in nasogenian folders and lips with good results.This device does not meet reporting requirements aligned with medical device reporting as the device is non-pma approved.

Manufacturer Narrative

Corrected data: b.2., b.5., d.1., d.4., g.4., h.1., h.6.

• Brand Name: JUVEDERM ULTRA 3/SMILE (VOLUME UNKNOWN)
• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17386106
• MDR Text Key: 319649036
• Report Number: 3005113652-2023-00603
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: -
• 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,Followup
• Report Date: 11/10/2023

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: 01/02/2024
• Device Catalogue Number: UNK JUVEDERM ULTRA 3/SMILE
• Device Lot Number: 1000500549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 11/03/2023
• Supplement Dates FDA Received: 10/13/2023; 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female