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

Catalog Number 94154ED

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

Patient Problem Herpes (1898)

Event Date 11/09/2019

Event Type  Injury  

Manufacturer Narrative

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.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 reported that the patient was injected with 1 ml of juvéderm ultra¿ xc in the lips.Topical numbing cream was applied with moderate effect.The patient was happy with the results.The lips were massaged.The patient was aware that may require more filler to achieve goals.The patient does not like the natural curve shape to bottom lip wants straighter and does not like cupids bows to be accentuated likes round shape.Over 2 weeks later the patient was reviewed.The patient was happy with the results.Very small lumps were felt to the right upper lip.Massaged to patient¿s satisfaction.The patient was injected in the upper lip with 4u of botox® for lip flip.Almost 3 months later, the patient was injected in the lips with 1 ml of juvéderm ultra¿ xc.Patient got in touch with the injector 4 days post treatment with a lot of swelling and blisters on the lip.The patient went to a pharmacist and they prescribed some treatment for cold sores.The patient was asked to return to the clinic to see an injector, but has not presented at this time.Injector has also asked patient for pictures and none have been received.The patient was pre-treated with numit 5% cream with moderate effect.The lips were massaged.The patient was aware that may require ¿lip flip to help evert¿.Patient got in touch with the injector 4 days post treatment with a lot of swelling and blisters on the left central upper lip.On the following day, the patient provided a photo of the lips to the facility with concerns of swelling.The patient stated to think ¿maybe an ulcer.¿ the patient was advised to attend the facility for review in person and the event ¿could be an ulcer/cold sore¿.The patient reported to otherwise be happy and didn¿t attend to the facility that day.The healthcare professional noted that the color on the picture did not look concerning.The patient was not concerned for the color.3 days later, the patient messaged the facility noting that the lips were ok.The patient provided a picture and the lips appeared much better; there was less swelling.Almost a week later, the patient reported ¿mild localized patch of blistering¿ appearing 3 days after injection.When the patient was reviewed on this day, the swelling was much better.There was small swelling where ¿? cold sore is¿.The patient went to the pharmacy and was given topical cold sore cream.By this day, blisters have resolved to dry small scab.The patient has history of ¿oral hsv¿ and did not take prophylactic famvir.The tenderness at the time of blisters has now resolved.The patient was feeling well by this day.The ¿oe small dry scab¿ is evident.Mild bruising from the injections remains on the lips.There are no other skin changes.¿likely hsv reactivation, mild¿ was noted as impression.¿valacyclovir 500mg bd for 10 days¿ was noted as the plan with review for progress a week later.The patient was reviewed 6 days later.Patient was happy with lip fillers.The patient was massaged.There were minimal lumps.The cold sore healed.The symptoms have not resolved but improved.Though the herpes is not device related, it is considered a serious, unexpected event.This is the same event and the same patient reported under mdr id# 3005113652-2019-00864 (allergan complaint # (b)(4)).This mdr is being submitted for the second juvéderm ultra¿ xc injection.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformance's noted.Additional data: b.5., b.6., h.6., h.8.

Event Description

Additionally, healthcare professional (hcp) reported that almost a week later from the last review, the hcp spoke to the patient who reported that it was all healed.The cold sores cream was specified as virasolve®.The patient reported going to the pharmacy that gave the virasolve® a day after patient provided a photo of the lips to the facility with concerns of swelling.

• 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 74370 ; FR 74370
• MDR Report Key: 9454321
• MDR Text Key: 185507553
• Report Number: 3005113652-2019-00863
• 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: 01/13/2020

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: 04/30/2021
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LA90258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUMIT 5% CREAM, MASSAGE.
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR