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

Catalog Number 94728ED

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076)

Event Date 04/08/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: docaine, botox®, aq chlorhexidine 0.1%, 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 firm lump, itchy, swelling, mild erythema and infection 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, erythema, infection, itching and skin irritation: precautions for use: ¿ "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.¿ induration or nodules at the injection site.".

Event Description

Healthcare professional reported injecting a patient with juvéderm® volbella® with lidocaine in the tear trough area, juvéderm® voluma® with lidocaine in the upper cheek and juvéderm ultra plus® xc in the nasolabial fold and mental crease.Patient was also injected with botox®.Prior to injection the patient had their skin cleansed with aq chlorhexidine 0.1% and given ice post injection.Patient was reviewed 4 weeks later and there was no concern.Two months after the injection, the patient had additional injections with juvéderm ultra plus® xc in the lid/cheek junctions and botox®.The patient again also had their skin cleansed with aq chlorhexidine 0.1% and given ice post injection.About 5 months later, the patient had developed lumps under the eyes.Patient claimed to have no previous illness and that the area just "started to feel bit itchy" and swelling in the area.Examination of the patient found a firm lump on the right tear trough with mild erythema surrounding and a "smaller on the left." there was also a firm lump on the left upper check/zygoma area with firm swelling of the left upper lateral cheek where the juvéderm® voluma® with lidocaine was injected.There was a similar, but less pronounced on right side.There was also firm swelling in the lower tear trough/lid/cheek junction on the right side with smaller swelling on the left side.The patient also had itching to the area later.There were no symptoms in the areas of the nasolabial fold or mental crease where juvéderm ultra plus® xc was initially injected.Patient was first treated with keflex.On the following day the patient was treated with prednisone and hyaluronidase.The tear trough/lid cheek junction areas "almost immediate softening and dispersion of the lumps" while the zygoma area had "persistent firm lump." on the next day, the patient had been reviewed and it was found that "the left tear trough lump completely dissolved" and the "right tear trough/lid/cheek area and left zygoma area lumps persisting but much smaller and softer." a few weeks prior to the symptoms, the patient had an mri with an iv contrast which the healthcare professional expressed that the patient "could've been contaminated with bacteria during the intravenous access for the mri contrast, which caused the infection where the fillers were injected 6 months prior, hence the delayed reaction to the fillers." patient continues to be reviewed and continues treatment with hyalase, prednisone and cephalexin as the "lumps kept on recurring" that were "consistently non-tender, and no signs of erythema of inflammation." patient had denied having any pain, discomfort or fever.Patient did mention having a sore throat and sinus congestion symptoms which were considered to be unrelated to the devices.Symptoms are ongoing.This is the same event and the same patient reported under mdr id #3005113652-2017-00263 ((b)(4)) and mdr id #3005113652-2017-00269 ((b)(4)).This mdr is being submitted for the second suspect product, juvéderm® volbella® with lidocaine, also a device manufactured by allergan.

Manufacturer Narrative

(b)(4).Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: 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.Device labeling for improper or incorrect procedure of method: "warnings check the expiry date on the product label.Juvéderm® volbella® with lidocaine gel must be used prior to the expiration date printed on the package.".

Event Description

Corrected information: the injection with juvéderm® volbella® with lidocaine took place about a month after the product had expired.

Event Description

Additional information: symptoms have resolved.

• 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: 6564941
• MDR Text Key: 75090222
• Report Number: 3005113652-2017-00268
• 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,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 94728ED
• Device Lot Number: V15LA40300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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: 50 YR