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

Catalog Number 94703ED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 03/27/2017

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 and delayed immune response 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 edema and hypersensitivity: "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 paraesthesia, occurring after the injection.These reactions may last for a week.In particular, it has to be noted that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of these tissues.Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended.¿ 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 ischaemia or cerebral haemorrhage, 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 injecting a patient with juvéderm® volbella® with lidocaine, juvéderm® volift® with lidocaine and unspecified juvéderm® voluma®.Patient was injected in the cheeks, lips and perioral area.Patient also had another injection for more juvéderm® volift® with lidocaine in the lips and perioral a month later.Two months later, the patient contacted the clinic and developed a delayed immune response that composed of "entire face swelling" that was "more significant in the perioral area." the healthcare professional is "managing the case." this is the same event and the same patient reported under mdr id #3005113652-2017-00277 ((b)(4)), mdr id #3005113652-2017-00278 ((b)(4)) and mdr id #3005113652-2017-00275 ((b)(4)).This mdr is being submitted for the fourth suspect product, the second injection with juvéderm® volift® with lidocaine, also a device manufactured by allergan.

Manufacturer Narrative

Concomitant therapies: ginkgo biloba and magnesium.(b)(4).The events of lumpy, sore, pimple, psoriasis and firm hard nodules are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device history record summary: the release step combined with the absence of any deviation shows that no element could explain this reaction: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.Additional device labeling for the reported events of pain, skin inflammation and skin irritation: 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: ¿ indurations or nodules at the injection site.".

Event Description

Additional information: the patient had a pimple that they "squeezed in area above lip on day swelling." patient reported to the clinic that their "lips have become swollen (that people have commented), lumpy, and sore." the lips were fine up until then.Patient was reviewed 4 days after symptoms appeared, who noted the "delayed immune response to filler." there was no trigger and the patient "gets psoriasis bloods." the patient had "lips firm hard nosules cheeks some swelling." patient had "massage face down" and treated with prednisone and keflex.Two days later, the patient was treated with hyalase after use of block led light.Patient was left with "firm swollen modules periorbital; swelling but cheek filler nasolabial line filler not indurated" and was also given prednisone, phenergan and keflex.Symptoms have resolved.Patient was concomitantly taking multi vitamins, fish oil, evening primrose oil, gingko biloba and magnesium.

• 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
• 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: 6537321
• MDR Text Key: 74209098
• Report Number: 3005113652-2017-00276
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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: 94703ED
• Device Lot Number: V17LA60363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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: 46 YR