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 Edema (1820); Numbness (2415); Patient Problem/Medical Problem (2688)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

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 swelling, numbness and droopiness 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.Adverse events ¿ the most common injection site responses for juvéderm® ultra xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.Functional features of the lips, including lip sensitivity, sensation, and speech were assessed before treatment and at follow-up visits after treatment.Minimal changes were noted in subject self-assessments of the function and sensation of the lips and mouth area, treating investigator assessments of other functional features of the lips and mouth area, evaluating investigator assessments of subjects¿ lip sensitivity, and speech and language pathologist assessments of subjects¿ speech and articulation at scheduled timepoints following treatment, thus demonstrating that lip function and sensation were unaffected by treatment with juvéderm® ultra xc.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

Healthcare professional reported after injection with 2ml of juvéderm® ultra xc in the nasolabial and melomental folds and 2ml of juvéderm voluma® xc in the cheeks, the patient developed swelling, numbness, and droopiness of the upper lip only on the right side of the mouth.Swelling and numbness occurred at injection sites for both products.Symptoms presented approximately 1 month post injection.Patient was also injected with botox® in the glabella and forehead lines.Patient was treated with muscle stimulation via electric probes, hyaluronidase, and tissue tightening via p500eve.Symptoms are ongoing.This is the same event and the same patient reported under mdr id #3005113652-2017-00545 (allergan complaint #(b)(4)).This mdr is being submitted for the first suspected product, juvéderm® ultra xc.

• 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: 6635022
• MDR Text Key: 77398454
• Report Number: 3005113652-2017-00544
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: (01)30888628000081(10)H24LA60500(11)161107(17)180407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Catalogue Number: 94154
• Device Lot Number: H24LA60500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• 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
• Patient Age: 67 YR