MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Healthcare professional reported to company representative that while a patient was being injected with juvéderm® ultra into the right upper lips.A large, dark bruise was noted on the left upper lip where 0.25 ml of juvéderm® ultra had just been placed.Further injections were stopped and perfusion was checked on the left upper lip.Perfusion was 3 seconds and blanching was noted above the vermilion border on the left side.Treatment was noted as hylenex, apply heat, cap refill, aspirin 650 mg given orally, 0.4 ml of a hylenex/lidocaine, 0.1 ml 2% xylocaine w/ epi 1:100,000, and 0.1 ml bacteriostatic 0.9% sodium chloride until patient reported no discomfort, pain, or other unusual symptoms.The next day, patent experienced minimal bruising above lip with no pain or discomfort and great perfusion.

Manufacturer Narrative

The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.

Event Description

Additional information reported symptom resolved on the same day of onset date.

Event Description

Healthcare professional reported to company representative that while a patient was being injected with juvéderm® ultra into the right upper lips.A large, dark bruise was noted on the left upper lip where 0.25ml of juvéderm® ultra had just been placed.Further injections were stopped and perfusion was checked on the left upper lip.Perfusion was 3 seconds and blanching was noted above the vermilion border on the left side.Treatment was noted as hylenex, apply heat, cap refill, aspirin 650mg given orally, 0.4ml of a hylenex/lidocaine, 0.1ml 2% xylocaine w/ epi 1:100,000, and 0.1ml bacteriostatic 0.9% sodium chloride until patient reported no discomfort, pain, or other unusual symptoms.The next day, patent experienced minimal bruising above lip with no pain or discomfort and great perfusion.

Manufacturer Narrative

Additional, changed, and/or corrected data.

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 15196189
• MDR Text Key: 297570497
• Report Number: 3005113652-2022-00501
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): Y
• 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,Followup,Followup
• Report Date: 09/06/2022

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 Expiration Date: 03/30/2022
• Device Catalogue Number: 94154
• Device Lot Number: H24LB00831
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/18/2022; 09/02/2022
• Supplement Dates FDA Received: 08/26/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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): Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female