MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94155EC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: antiseptic.This is a known potential adverse event addressed in the product labeling.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.

Event Description

Healthcare professional (hcp) reported injecting a patient in the lip deep with 0.1 ml of juvéderm ultra plus¿ xc.This was not the initial use of the syringe.The patient was pre-treated with anesthetic and antiseptic.The patient was concomitantly taking telmisartan, antihypertensive.3 days later, the patient presented ¿supralabial whitening with hematoma on the left upper lip mucosa and submuscosa with posterior edema of the upper lip.¿ the event was also described as ¿whitening, bruising, inflammation / edema and livedo¿.A day later, an ultrasound of soft tissue with doppler showed ¿inflammation without vascular alteration.¿ on the same day, the patient was treated with ketrolac, intralesional hyaluronidase mesoestetic®, fecofenadine 182 mg / day, aspirine, meprednisone 40 mg / day, levofloxacine, and fusidic acid local cream.According to the hcp, the treatment was provided to hasten resolution and avoid permanent damage, tissue necrosis.The hcp considered the event a life-threatening injury or illness.The event did not cause a permanent lesion.The symptoms resolved 10 days later.

Manufacturer Narrative

Additional, corrected, and/or changed data: b.5., d.6., h.6.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Additionally, the healthcare professional (hcp) reported that the initial use of the syringe occurred 15 days prior to the reported use.The hcp clarified that the hyaluronidase mesoestetic® and fexofenadine treatments occurred on the same day.On the following day, the patient was treated with ketorolac due to pain and hypersensitivity.At 48 hours, meprednisone 40 mg, aspirin, and oral levofloxacin antibiotic with local antiseptic alibour water, plus topical cream of fusidic acid, were administered.The hcp continued with cicaplast b5 on the successive days.

• Brand Name: JUVEDERM ULTRA PLUS XC 1 ML ROW
• 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
• MDR Report Key: 9749977
• MDR Text Key: 190191149
• Report Number: 3005113652-2020-00106
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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: 02/28/2021
• Device Catalogue Number: 94155EC
• Device Lot Number: H30LA90171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIHYPERTENSIVE (TELMISARTAN), ANESTHETIC.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 45 YR