MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUX XC 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 20073770

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

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2023

Event Type  Injury  

Event Description

Healthcare professional reported that a patient was injected with juvéderm® volux¿ xc in right jawline.5 months later, patient experienced hypersalivation, pain and tightness like radiating from their ear area and down to the shoulder, along the sternocleidomastoid muscle in right neck.An ultrasound noted filler in parotid gland.150u of hylenex used to dissolved filler.The patient was prescribed prednisone (60mg x 3-day, 40 mg x 3 day, and 10mg x 3 day).Hypersalivation has been resolved but neck tightness still present.

Manufacturer Narrative

Clarification to section c.Suspect product: lot number 980/1.Continued h.6.Type of investigation code: b15, b18, b20.Clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe has been discarded.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.The event of "hypersalivation" is considered an unexpected adverse drug experience.

Event Description

Per medical review, the event of hypersalivation is deemed not a serious injury.

Manufacturer Narrative

Previous medwatch submission noted hypersalivation as a serious injury.Abbvie medical safety determined that the event of hypersalivation is not considered a serious injury.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• 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: 18196726
• MDR Text Key: 328883056
• Report Number: 3005113652-2023-00922
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: 10840228300073
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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 Catalogue Number: 20073770
• Device Lot Number: 1000565587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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: 26 YR
• Patient Sex: Female