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

Catalog Number 94154ED

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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

Healthcare professional reported that patient was injected with juvéderm ultra® xc.Patient reported no issue with the healing process after and was happy with the aesthetic outcome.Three months and a week later, patient noticed a blister develop.Five days later, ¿the blister popped and [patient] noticed a thick fluid/material came out that [patient] described as being like filler, with no other liquid or blister contents.¿ five days later, patient came into the office and advised that the area healed well thereafter and that there was no further issue and described nothing that sounded like infection.The area that [patient] reports the blister was in the inside of the lower left lip, approximately 4-6mm from the wet/dry border.The area [hcp] observed was not part of the original treatment area and on palpation [hcp] could feel no filler or signs of migration near the blister area.The [patient] has been fit and well and reports no periods in between treatment and now of illness.The area has not been red, hot, inflamed or painful for the [patient] and no signs of trauma in the surrounding areas of the mouth, gums of tongue were observed.[hcp] recommended the client keep the area as clean as possible.

Manufacturer Narrative

Additional, corrected, and/or changed data: a.1., b.5., b.6., d.10., g.1., h.6., h.8.Clarification to h6: the filler was injected into the patient and is not accessible for return.The syringe was discarded.A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Additional information reported that patient was injected with 1 ml juvéderm ultra® xc.Hcp noted the etiology as "i don't believe so, given the amount of time between the date of treatment and the date of the client reporting the blister." no treatment was provided and it was noted "the client, between reporting and an assessment be myself, had healed the blister and with no residual symptoms." event has resolved 10 days post day of onset.

• Brand Name: JUVEDERM ULTRA XC (1 ML COC)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• MDR Report Key: 12089166
• MDR Text Key: 266171027
• Report Number: 3005113652-2021-03060
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LB00372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR