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

Catalog Number 94154

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that a patient was injected in the ¿cheek, levator labii superioris alaeque nasi¿ with 2 syringes of juvéderm voluma® xc and in the nasolabial fold, marionette lines, and pre-jowl sulcus with 2 syringes of juvéderm® ultra xc.The next day, the patient was injected by another injector in the upper lip with 1 syringe of juvéderm volbella® xc.Topical blt was used as anesthetic during the injections.About 10 months later the patient started a new skin line, no7, which she stopped.On the following month, the patient developed ¿hard lumps with erythema in first right medial tear trough bilateral tear troughs.¿ the patient saw their ophthalmologist the following months and was put on keflex 250 mg 3x/day for 10 days.Patient saw another healthcare professional the next month.They had a ¿red lump, left medial tear trough area.¿ healthcare professional ordered an mri.Patient had their eyes done that month and showed masses in the bilateral infraorbital region, measuring approximately 0.6 x 2.8 x 1.9 cm on the right, and 2.5 x 1.3 x 1.3 on the left.Differential diagnosis included injectable facial filler material, fibromas or less likely a tumor.This antibiotic did not initially help patient.A biopsy was also performed on the left lower eyelid/cheek the next month, which showed foreign body-type granulomatous inflammation with fat necrosis.It was noted that ¿the changes are associated with mucinous material and could represented ruptured cyst, foreign material or other.Healthcare professional had offered to use hyaluronidase to dissolve away, but the patient declined initially since things had settled down and the patient did not want to lose volume.The patient felt like the areas of the cheeks improved over time, the erythema went away, the edema improved but still has firm areas.The patient noticed a new area of puffiness above the right upper lip.The patient has no pain to the nodules, but if the patient manipulates or rubs them they sometimes feel a bit tender.The patient had an exam and had ¿no signs of redness, a firm nodule to the right malar inferiorly eminence about 1 cm, on malar eminence more superior and lateral about 6 mm, on left lower lid along the orbital rim, just lateral to pupil line 6 mm, to left malar eminence about 1 cm, bilateral firm nodules next to nasal alar about 8 mm and fairly deep, and nodule to right upper lip that is about 8 mm, left upper lip, a few firm areas in vertical lines.¿ the areas are not painful but do feel tender and on deep palpation.Treating physician explained that it appears to be inflammatory delayed onset nodules.The patient was started on 2-week course of antibiotics.The patient was given doxycycline 100 mg twice a day for 2 weeks and then would reassess.The patient will also undergo right shoulder surgery.This is the same event and the same patient reported under mdr id # 3005113652-2019-00707 (allergan complaint # (b)(4)) and mdr id # 3005113652-2019-00709 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra xc, also a device manufactured by allergan.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Additionally, the healthcare professional (hcp) clarified that the hard lumps with erythema were first developed to the right medial tear trough, then bilateral tear throughs.The mri performed also showed a mild paranasal sinus disease without an air-fluid level.The mass lesions in the right were greater than the left infraorbital region.When talking about the patient¿s history, the hcp noted that the patient gets frequent sinus infections.Over 2 weeks from the doxycycline 100 mg twice a day for 2 weeks treatment, the patient followed up with the hcp for the delayed inflammatory nodules.At that time the patient felt that swelling in the lips had settled down and had not developed redness.Palpable nodules were still present in the right and left malar regions, but the left orbital rim nodule seemed to have resolved.Right upper lip had swelling but left upper side looked better.Hcp did not feel much at the top of the nasolabial fold.Patient continued on another 2-week course of doxycycline 100mg bid.The patient was offered hyaluronidase to dissolve, but the patient did not want to lose the volume and declined.2 days after this, the patient underwent shoulder surgery.Over a month later, the patient followed up with the hcp.After the doxycycline was stopped, the patient did not have any changes or flareups after that.On exam, patient had two nodules of 1 cm palpable on the left zygomatic arch, slightly visible, but no sign of redness or infection.The patient also had a cluster of small nodules that were less defined on the malar area, left cheek; 2 of them were centrally and 3 small ones were more laterally.These had no signs of redness and were not visible on the skin surface.Lips had ¿fullness and small cluster of 2 small nodules, right upper lip and left upper lip with very small nodule laterally¿.Hcp recommended restarting doxycycline and hyaluronidase treatment.Patient agreed.Injected both left zygomatic arch nodules, right malar nodules, and right/left upper lip using total 1.5cc.Patient had follow-up appointment but had to cancel due to developing a cold.The patient felt it was likely a mild sinus infection.Patient didn¿t seek medical attention as the patient gets them frequently.The patient self-treated with mucinex, no antibiotic.The hcp spoke to the patient by phone almost a month after the last follow up.The patient reported to have had topped the antibiotics 2 weeks after the last follow up because of stomach upset and intolerance to the antibiotic.These resolved when the patient stopped the antibiotic treatment.He patient has not had any problems since stopping the antibiotic.The patient feels that the lip fullness in the right upper lip and nodules in both cheeks have improved and gone down.Over 2 weeks later, the patient attended to the facility for face recheck.The patient has not had any type of flareups since the hyaluronidase treatment.On exam hcp felt one tiny nodule about 5 mm over the lateral right zygomatic arch, but difficult to feel.The hcp did not feel any nodularity on left cheek and no puffiness or nodularity on lips.Patient is doing very well with nearly all nodules resolved except for one tiny one.The patient does not want any further hyaluronidase injections, as the patient already misses volume loss.The hcp doesn¿t think it is necessary either.

• 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 74370 ; FR 74370
• MDR Report Key: 9183251
• MDR Text Key: 165979956
• Report Number: 3005113652-2019-00708
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA70666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM VOLUMA® XC, TOPICAL BLT, ICE.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR