MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Edema (1820)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable.The events of puffy and swelling are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: intended use/indications juvéderm® ultra plus 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).Precautions ¿ the safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds (eg, lips) have not been established in controlled clinical studies.Adverse events per table 1: injection site responses by maximum severity occurring in > 5% of treated subjects, possible injection site responses post injection with juvéderm® ultra plus include: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and 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, antiinflammatories, 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 one syringe of juvéderm® ultra plus in the tear troughs as well as one syringe of juvéderm vollure¿ xc under right eye.Within one week after injection patient's eyes developed "swelling and puffiness." patient presented to the office nine days later and was treated with hyaluronidase.Patient had a 2nd treatment of hyaluronidase a week later.Symptoms are ongoing.Patient also mentioned they believe the juvéderm® used was "off label." this is the same event and the same patient reported under mdr id# 3005113652-2017-01647 ((b)(4)).This is the first mdr submitted for the first suspect product, juvéderm® ultra plus.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)
• 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: 7151397
• MDR Text Key: 96012702
• Report Number: 3005113652-2017-01646
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• 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

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR