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

Catalog Number 94703ZQ

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

Patient Problems Skin Erosion (2075); Vascular System (Circulation), Impaired (2572); Tissue Breakdown (2681)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

(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 blanching, occlusion, loss of skin, loss of muscle, loss of mucosa and contour irregular are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling: contra-indications: do not inject into the blood vessels (intravascular).Intravascular injection may lead to embolization, occlusion of the vessels, ischemia or infarction.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: staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect).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.Method of use - posology if immediate blanching occurs at any time during the injection, the injection should be stopped and appropriate action taken such as massaging the area until its return to a normal color.

Event Description

Healthcare professional reported injecting a patient with juvéderm volift with lidocaine in the nasolabial folds, marionettes and lips.Patient was also injected with juvéderm voluma with lidocaine in the cheeks.Patient immediately developed blanching on the right upper lip post injection.Although the patient had only developed blanching in the lips, it was suspected that the patient had occlusion in the marionette even though there were no initial display of symptoms.Patient was immediately treated with hyaluronidase and 2 more times over the next 3 days.Patient had also been given prednisone 2 days after the injection.Four days after the injection, the patient had a hyperbaric chamber treatment for the next 2 days.Patient symptoms have resulted in permanent damage as the patient has had a loss of skin, muscle, mucosa and contour irregular.

Manufacturer Narrative

Additional information: devices history record found no significant anomalies.No deviations or non-conformances were found.

Event Description

Healthcare professional reported injecting a patient with juvéderm volift with lidocaine in the nasolabial folds, marionettes and lips.Patient was also injected with juvéderm voluma with lidocaine in the cheeks.Patient immediately developed blanching on the right upper lip post injection.Although the patient had only developed blanching in the lips, it was suspected that the patient had occlusion in the marionette even though there were no initial display of symptoms.Patient was treated with immediately treated with hyaluronidase and 2 more times over the next 3 days.Patient had also been given prednisone 2 days after the injection.Four days after the injection, the patient had a hyperbaric chamber treatment for the next 2 days.Patient symptoms have resulted in permanent damage as the patient has had a loss of skin, muscle, mucosa and contour irregular.

• 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: 8078940
• MDR Text Key: 127409083
• Report Number: 3005113652-2018-01341
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 94703ZQ
• Device Lot Number: V17LA80128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVEDERM VOLUMA WITH LIDOCAINE; JUVEDERM VOLUMA WITH LIDOCAINE
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 51 YR