MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: late 30's.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 "vascular occlusion " 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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient near the preauricular area, zygomatic arch, submandibular and jawline with 4 syringes of juvéderm® voluma¿ xc and in the temples with juvéderm® ultra plus.On the second day, the patient experienced ¿some reticularis and pressure.¿ the healthcare professional suspect that they ¿may have injected in the angular artery¿ and described the vascular occlusion as ¿widespread,¿ noting that they saw some reticularis on the other side of the nose, essentially affecting both sides of the nose.Treatment included 36 vials of hylenex, hyperbaric treatment twice a day, e02 patch oxygenation, cutagenix¿ cream, daily aspirin, acyclovir, keflex, and sildenafil.More hylenex treatment is planned.The event is ongoing.This is the same event and the same patient reported under mdr # 3005113652-2022-00114 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra plus.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13625512
• MDR Text Key: 286441076
• Report Number: 3005113652-2022-00115
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLUMA¿ XC
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female