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

Catalog Number	UNK JUVEDERM ULTRA XC/LIDO
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article citation: chuchvara, nadiya, et al.¿dermal filler-induced vascular occlusion successfully treated with tadalafil, hyaluronidase, and aspirin.¿ dermatologic surgery, publish ahead of print, 2021 apr 13.Crossref, doi:10.1097/dss.0000000000002894.Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.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 or Problem Description
Health professional reported in the article ¿dermal filler-induced vascular occlusion successfully treated with tadalafil, hyaluronidase, and aspirin¿ that a patent was injected in the lips with juvéderm® ultra xc.Two hours later, the patient reported ¿intense pain¿ and the right upper mucosal and cutaneous lip appeared ¿blackened with an overlaying pale blue tinge.The patient was instructed to take oral aspirin 325 mg and immediately return for treatment of ¿suspected dermal filler-induced arterial occlusion.¿ the patient was treated with 300 iu of hylenex and subsequently massaged to prevent necrosis and was given tadalafil 10 mg.Blood pressure and pulse were monitored.Two hours later, the ¿blanched¿ area acquired a ¿violaceous tinge, which expanded inward to filler the entirety of the affected area 12 hours later.At this point, the patient received 300 iu of hyaluronidase and 325 mg of oral aspirin and was instructed to apply warm compresses.On the third day, ¿pustules and erythema¿ developed in the area of prior ¿ischemia, likely from microcirculation involvement.¿ the patient was advised to apply triamcinolone 0.1% ointment.Ten days after the initial injection, there was near-complete resolution, mild residual erythema, no tissue atrophy, the pustules healed, and the patient recovered without scarring.A month later, the site was treated with fractional carbon dioxide laser to address the an atrophic scar at the superior edge of the right upper cutaneous lip from prior trauma and the reason the patient wished to get the injection, achieving satisfactory cosmetic results by 5 months.¿.

• Brand Name: JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)
• Common Device Name: 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: 11896439
• Report Number: 3005113652-2021-00461
• Device Sequence Number: 3845693
• Product Code: LMH
• Combination Product (Y/N): Y
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA XC/LIDO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR