MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA/24HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

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. Clarification: 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 reports 1ml juvéderm ultra¿ injection into the upper/lower lips, asymmetries corrected. Bruise to upper r lip the day of injection. Patient experienced a vascular occlusion 3 days later. Client sent photos to the injector after becoming concerned with bruising upper l under nostril area and 2 small blisters to the area that popped with small amount of blood. Hylase x2 vials 5ml lido 1% dilution provided near affected area and down to the upper lip later that day after noticing slightly delayed capillary refill. Massaged nostril area and upper lip areas. Capillary refill improved, but still slightly delayed, but client felt immediate relief of pain and the slight firmness aof the affected area had dissipated. Arnica, hiradoid, aspirn and heatpacks advised. The following day, client felt better, no where near as much pain and no bruising. Capillary refill improved, but still slightly delayed to affected area. Small black/purple bruise formed corner upper left lip from hylase session the previous day. Hyperdiluted hylase 1 vial used with 3ml 1% lido applied to affected site. Led therapy and massage after treatment. O2 therapy also provided to calm/settle patient as client was in tears from pain. Arnica, hiradoid, aspirn and heatpacks again advised. Progress and recover went well. 10 days later, discoloration and pain had improved and capillary refill normail, <3 secs. It was a traumatic journey for patient and injector as this was the first time either had experienced it. Patient was cooperative and very understanding.

• Brand Name: JUVEDERM ULTRA/24HV (VOLUME UNKNOWN)
• 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): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10374005
• MDR Text Key: 201896573
• Report Number: 3005113652-2020-00430
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK JUVEDERM ULTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/04/2020
• 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: Initial

Patient Treatment Data

Date Received: 08/06/2020 Patient Sequence Number: 1