MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94703RX

Device Problem Migration (4003)

Patient Problems Cyst(s) (1800); Inflammation (1932); Skin Irritation (2076)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: juvéderm¿ voluma¿ with lidocaine, ice.(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 edema, nodule, nodule migration which looked like a "chalazion," and granuloma due to probably migration of product are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: undesirable effects: the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of theses tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.Induration or nodules at the injection site.Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression 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 structures.Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of 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 medical practitioner specialist should an intravascular injection occur.Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.It is therefore advisable to take these potential risks into account.

Event Description

Healthcare professional reported that a patient was injected in the dark circles with juvéderm® volbella¿ with lidocaine, in the malar and ck1, 2, and 3 with juvéderm® volift¿ with lidocaine, and juvéderm¿ voluma¿ with lidocaine.Post treatment included ice.About one month later, the patient developed edema below the eyelid.Then, a nodule developed on the lower border of eyelid, which migrated and looked like a ¿chalazion.¿ healthcare professional felt a granuloma was present 3 months following injection.Lower eyelid nodulation was also reported and treatment with a saline solution/lidocaine injection and massage was given 5.5 months following first sign of edema.Ten days after treatment, healthcare professional assessed as lower eyelid nodule, suggestive of granuloma, due to probable migration of the product.After the saline/lidocaine injection, product migrated to the eyelid border.Symptoms are ongoing.Healthcare professional feels the event caused a permanent lesion and surgical intervention may be necessary.Patient plans to have plastic surgery due to dissatisfaction with results of the event.It was reported that the patient is sad about the situation.This is the same event and the same patient reported under mdr id #3005113652-2018-00850 ((b)(4)) and mdr id #3005113652-2018-00852 ((b)(4)).This is the second mdr submitted for the 2nd suspected product, juvéderm volift with lidocaine.

Event Description

Additional information: patient had to undergo drainage of the lower eyelid nodule by a plastic surgeon.Patient did not need to use antibiotic or corticoid therapy.

Manufacturer Narrative

Additional information:.

• Brand Name: VOLIFT WITH LIDOCAINE
• 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
• MDR Report Key: 7687341
• MDR Text Key: 113961289
• Report Number: 3005113652-2018-00851
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 94703RX
• Device Lot Number: V17LA60328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE; JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE
• Patient Outcome(s): Disability
• Patient Age: 55 YR