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

Catalog Number 94728JR

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

Patient Problems Abscess (1690); Cellulitis (1768); Foreign Body Reaction (1868)

Event Date 12/09/2016

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 dental abscess draining into right cheek causing cellulitis, injection sites became hard, indurated, swollen, and granulomatous with facial disfigurement, extreme swelling, change in sensation and pins and needles, and fillers acted as foreign bodies attacked by the inflammatory processes are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported events as follows: precautions for use "as a matter of general principle, injection of a medical device is associated with a risk of infection." undesirable effects: "the patients must be informed that there are potential side effects associated with implantation of this device, which may occur immediately or may be delayed.These include (non-exhaustive list) : inflammatory reactions (redness, oedema, erythema, ¿) which may be associated with itching, pain on pressure, 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.Poor effect or weak filling effect.Cases of necroses in the glabellar region, abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have been reported.It is therefore advisable to take these potential risks into account.".

Event Description

Patient, who is also an orthodontist, reported injecting themselves with 1 ml of juvéderm® volbella¿ with lidocaine in the lips and 1 ml of juvéderm® voluma¿ with lidocaine in the cheeks.Approximately eight months later patient developed a "dental abscess ur draining into right cheek causing cellulitis." after this "all injection sites previously done became hard, indurated, swollen and granulomatous with facial disfigurement." patient also had extreme swelling, change in sensation and pins and needles in the injected areas in the lips and cheeks.The fillers were noted to have "acted as foreign bodies attacked by the inflammatory processes." patient consulted a plastic surgeon who prescribed 5 weeks of antibiotics and anti-inflammatories, including megapen, moxibay, ciprobay, augmentin, celestamine, cataflan, flagyl, pulmison, and myprodol.Symptoms are ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2017-00082 ((b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volbella¿ with lidocaine, also a device manufactured by allergan.

Manufacturer Narrative

The documentary research in the batch file shows that no element could explain this issue: 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.

Event Description

Patient clarified that they only injected theirself with juvéderm® voluma¿ with lidocaine.Patient was injected by another physician 3 months later with juvéderm® volbella¿ with lidocaine.

• 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: 6398702
• MDR Text Key: 69757271
• Report Number: 3005113652-2017-00083
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA60055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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® VOLUMA¿ WITH LIDOCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR