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

Catalog Number 94728ED

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

Patient Problems Cellulitis (1768); Edema (1820); Blood Loss (2597)

Event Date 04/07/2017

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 very swollen face, puffy, pain, hyperaemic, cellulitis and minimal bleeding 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: "precautions for use ¿ patients on anti-coagulation medication or using substances that can prolong bleeding (warfarin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as herbal supplements with garlic or ginkgo biloba, etc.) must be warned of the potential increased risks of bleeding and haematomas during injection.¿ as a matter of general principle, injection of a medical device is associated with a risk of infection.Standard precautions associated with injectable materials should be followed.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.".

Event Description

Healthcare professional reported patient was injected with 2ml of juvéderm® volift® with lidocaine in the nasolabial fold and lower forehead as well as 1ml of juvéderm® volbella® with lidocaine in the tear trough, frown finelines and lid cheek junction.Patient was given a "pain block" prior to injection.There was minimal bleeding.About two months later, the patient had a delayed reaction of a "very swollen face." patient was sent to the hospital by their general practitioner.Patient developed the symptoms about 10 days prior to being admitted to the hospital.The patient noted it started with discomfort which progressed to left cheek swelling and then the right cheek.The patient's general practitioner prescribed augmentin which the patient did not have fever or chills.On examination of the patient, they had "puffy eyes and cheeks.Hyperaemic.Eyelids swollen, but not vision impaired." patient was treated with iv antibiotics for a possible infection.Differential was "a reaction to the juvéderm but very delayed presentation." patient was reviewed by a senior medical officer which had the impression that it was "more cellulitis".Patient improved with antibiotics and antihistamine.It was also noted that the patient was "not unwell so thought no need for acute hospital stay." patient had been given flucloxacillin for "facial ? cellulitis" paracetamol for pain and promethazine hydrochloride upon discharge.Patient was discharged from the hospital after 2 days and 1 night and advised to continue taking flucloxacillin.On the following day, the patient was treated with hyalase by the injecting healthcare professional and symptoms resolved the day after that.This is the same event and the same patient reported under mdr id #3005113652-2017-00820 ((b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volbella® with lidocaine, also a device manufactured by allergan.

• Brand Name: VOLBELLA 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: 6796300
• MDR Text Key: 82755163
• Report Number: 3005113652-2017-00821
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 94728ED
• Device Lot Number: V15LA60067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• 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
• Treatment: JUVÉDERM® VOLIFT® WITH LIDOCAINE, PAIN BLOCK
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR