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 Autoimmune Reaction (1733); Unspecified Infection (1930); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.The events of "possible infection," "blisters," and "mucous membrane pemphigoid" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: "warnings: injection site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting = 7 days in facial wrinkles and folds, and typically last = 14 days in the lips.Refer to the adverse events section for details.Precautions: as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.Adverse events: the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.Postmarket surveillance the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma.In many cases, the symptoms resolved without any treatment.Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress.".

Event Description

Patient reported they were injected with less than one syringe of juvéderm® ultra xc in the lips and "sides of the lips." about a week after injection patient developed "possible infection" and blisters at the injection areas.Patient additionally noted the blisters are "all on the inside of the mouth" and there is nothing on the outside of the mouth.The patient was prescribed bactrim and metronidazole by a dentist.The patient was also prescribed tacrolimus and a "magic mouthwash" by a periodontist who believes the patient is suffering from mucous membrane pemphigoid.The patient indicated they are going to have an allergy test administered soon to rule out an allergy to the juvéderm®.Symptoms are ongoing.

• 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
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 7152961
• MDR Text Key: 96002434
• Report Number: 3005113652-2017-01713
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/28/2017

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: 09/20/2018
• Device Catalogue Number: 94154
• Device Lot Number: H24LA70234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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): Required Intervention