MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (2 X 0.4 ML); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	93899
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Erythema (1840); Skin Irritation (2076)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of ¿redness and bumps¿, ¿swelling¿, and ¿erosions¿ 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 events 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: ¿"the safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds, lips, and perioral area have not been established in controlled clinical studies." adverse events: ¿"the most common injection-site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising." post-market 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, necrosis, infection, migration, paresthesia, dry skin, abscess, headache, malaise, flulike symptoms, vision abnormalities, scarring, nausea, drainage, dyspnea, syncope, dizziness, anxiety, granuloma." ¿"in many cases, the symptoms resolved without any treatment.Reported treatments have included: oral or injectable 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." ¿"scarring has mostly been reported after treatment in the forehead or glabellar region and associated with a vascular event, necrosis, skin discoloration, blister, nodule, allergic reaction, and infection.Time to onset ranged from 2 weeks to 4 months.Interventions prescribed by the physicians included topical steroidal cream, nitropaste, oral steroids, and antibiotics.Additional treatments noted were a laser procedure and surgical scar revision.".
Event or Problem Description
Healthcare professional reported that 2 days after injection in the glabella with juvederm® ultra plus the patient developed redness, swelling, and bumps at an unspecified site.The symptoms are resolving slowly with hyaluronidase, oral steroids, antibiotics, antiviral, nitroglycerin paste, hyperbaric oxygen therapy, and warm compress.Patient was concomitantly injected with 25 units of botox in the glabella.The patient's still was tested later to see if it may be allergic, but that was negative.Symptoms are ongoing.
Additional Manufacturer Narrative
Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The sterilization cycle is registered as conforming.
Event or Problem Description
Healthcare professional reported that 2 days after injection in the glabella with juvederm® ultra plus the patient developed redness, swelling, and bumps at an unspecified site.The symptoms are resolving slowly with hyaluronidase, oral steroids, antibiotics, antiviral, nitroglycerin paste, hyperbaric oxygen therapy, and warm compress.Patient was concomitantly injected with 25 units of botox in the glabella.The patient's still was tested later to see if it may be allergic, but that was negative.Symptoms are ongoing.
Event or Problem Description
Additional information received from healthcare professional that symptoms have resolved as of (b)(6) 2016.

• Brand Name: JUVEDERM ULTRA XC (2 X 0.4 ML)
• Common Device Name: 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: 6053405
• Report Number: 3005113652-2016-00824
• Device Sequence Number: 1838265
• Product Code: LMH
• UDI-Device Identifier: 30888628000074
• UDI-Public: (01)30888628000074(10)H24LA60280(11)160621(17)171121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2017
• Device Catalogue Number: 93899
• Device Lot Number: H24LA60280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 11/01/2016; 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT 25 UNITS BOTOX® IN GLABELLA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR