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

Catalog Number 94154

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Edema (1820); Erythema (1840); Skin Inflammation (2443)

Event Date 07/23/2018

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 events of "redness, swelling, and white papules " are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. 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. Device labeling: intended use/indications: juvéderm® ultra xc injectable gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Juvéderm® ultra xc is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21. 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. Adverse events: the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising. Table 1 and 2. Injection site responses by maximum severity and duration. Possible treatment site responses: redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration. 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 called and reported that they were injected with less than 1 syringe of juvéderm® ultra xc in the nose and three days later the patient experienced redness, swelling, and white papules at the injection site. The day symptoms began the patient, also a healthcare professional, self-prescribed bactrim. Symptoms resolved 2 days after they began.

• 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: 7970818
• MDR Text Key: 123880610
• Report Number: 3005113652-2018-01347
• Device Sequence Number: 1
• Product Code: LMH
• 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,health professional
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/05/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80253
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/16/2018 Patient Sequence Number: 1