MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA (VOLUME/ADDITIVE UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM VOLUMA-ADDITIVE

Device Problems Migration or Expulsion of Device (1395); Overcorrection (3006)

Patient Problems Edema (1820); Pain (1994)

Event Date 06/15/2017

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 pain 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 for the reported events of pain, edema, migration of device or device component and overcorrection: warnings: the product must not be injected into blood vessels.Introduction of juvéderm voluma® xc into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.Take extra care when injecting soft tissue fillers, for example, after insertion of the needle, and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly and apply the least amount of pressure necessary.Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure.Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur (see health care professional instructions #14).Adverse events: per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment, possible treatment site responses after injection with juvéderm voluma® xc include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.Postmarket surveillance: juvéderm voluma® without lidocaine has been marketed outside the u.S since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013.The following aes were received from postmarket surveillance for juvéderm voluma® 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 aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.Instructions for use: health care professional instructions.Correct to 100% of the desired volume effect.Do not overcorrect.The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue, and the injection technique.Markedly indurated defects may be difficult to correct.The area of lost facial volume should be lifted by the end of the injection.When injection is completed, the treated site may be gently massaged to mold the product to the contour of the surrounding tissue and assure that it is evenly distributed and conforms to the contour of the surrounding tissues.If overcorrection occurs, massage the area between your fingers or against an underlying superficial bone to obtain optimal results.Patients may experience treatment site responses, which typically resolve within 2 to 4 weeks.Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.Patient instructions: it is recommended that the following information be shared with patients: within the first 24 hours, patients should avoid strenuous exercise and extensive sun or heat exposure.Exposure to any of the above may cause temporary redness, swelling, and/or itching at the treatment sites.If the treated area is swollen, an ice pack may be applied to the site for a short period.

Event Description

Patient reported being injected with unspecified juvéderm® voluma® in the chin (c1, c2).Patient noted having immediately felt "sharp pain" which "seemed to be okay for the rest of the session." patient noted that they had "ended up with a swollen bottom lip" that was bilateral.Patient thinks "something may have been pranged" and noted to be "slowly recovering" since the injection.Two weeks after the injection, the patient was treated with hylase.About 4 weeks after that, the patient had another injection with juvéderm ultra® xc in the lips since their "old filler" had dissolved when they had been treated with hylase.The "same area that had filled with filler in the right side of lip filled again and further hylase was needed." patient had consulted a physician who "thought that the [unspecified juvéderm® voluma®] in [the patient's] mental crease had created a channel into [their] low lip and a pocket on the right side.Which wasn't noticed until after the [juvéderm ultra® xc] was injected as it also migrated 2 weeks later into the same right side pocket of the lower lip." the physician had wondered if the volume to the mental crease "was too much and the filler escaped into the lip causing the channel." symptoms have resolved.This is the same event and the same patient reported under mdr id #3005113652-2017-01131 (allergan complaint # (b)(4)).This is the first mdr submitted for the first suspected product, unspecified juvéderm® voluma®.

• Brand Name: JUVEDERM VOLUMA (VOLUME/ADDITIVE 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: 6877888
• MDR Text Key: 86701030
• Report Number: 3005113652-2017-01032
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM VOLUMA-ADDITIVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR