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

Catalog Number 96655JR

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

Patient Problems Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

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.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient reported being injected with unk dermal filler.At the end of the day, patient experienced swellng on the whole jaw and chin, in so much pain, patient couldn't open the mouth.Patient had hard time chewing food.Patient have deformities and decompensated inflammations of the jaw.The next day, patient woke up with same pain and took ibuprofen for inflammation.Symptoms are ongoing.

Manufacturer Narrative

Additional, changed, and/or corrected data: a4, a5, a6, b5, d1, d4, g1, g4, h6.

Event Description

Additionally, patient reported being injected with juvéderm volux xc and inflammation more in the lower third.They have been treated with corticosteroids.Symptom resolved.

Manufacturer Narrative

H.11: previous emdr submission noted the event code inflammation.However, per medical assessment, event code is not serious injury.

Event Description

Patient reported being injected with unk dermal filler.At the end of the day, patient experienced swellng on the whole jaw and chin, in so much pain, patient couldn't open the mouth.Patient had hard time chewing food.Patient have deformities and decompensated inflammations of the jaw.The next day, patient woke up with same pain and took ibuprofen for inflammation.Symptoms are ongoing.

• Brand Name: JUVEDERM VOLUX 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 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; zone artisanale de pre-mairy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18647453
• MDR Text Key: 334612717
• Report Number: 3005113652-2024-00082
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 96655JR
• Device Lot Number: 1000552542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 65 KG