MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

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

Patient Problems Abscess (1690); Edema (1820); Unspecified Infection (1930); Scarring (2061); Skin Inflammation (2443)

Event Date 04/08/2017

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 abscess and pustules 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 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 the reported events of abscess and skin inflammation: "warnings: treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks.Refer to the adverse events section for details.Adverse events: clinical evaluation of juvéderm voluma® xc: device/injection-related adverse events occurring in = 1% of subjects included injection site hypertrophy (0.7%), nodule (0.7%), inflammation (0.4%), injection site anesthesia (0.4%), injection site dryness (0.4%), injection site erosion (0.4%), mass (0.4%), contusion (0.4%) and syncope (0.4%).Two subjects (0.7%; 2/270) reported 3 serious adverse events (saes) that were considered to be related to the device.Approximately 6 months after treatment, after being scratched near the treated area by a tree branch, one subject experienced inflammation under the left eye.The subject also experienced nodularity in the right cheek approximately 7 months after treatment.The second subject experienced lumps in the cheeks approximately 7 months after treatment.A couple of days before the onset, the subject experienced myofascial pain and body aches.Treatment of the saes included topical steroids, oral antibiotics, intralesional steroids, anti-inflammatory medication, and hyaluronidase.All events resolved.Other safety data: postmarket surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® xc (also known as juvéderm voluma® with lidocaine) has been marketed outside the us since 2009 and in the us since 2013.The following aes were received from postmarket surveillance for juvéderm voluma® with and without lidocaine with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through postmarket surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, allergic reaction, abscess, paresthesia, vascular occlusion, drainage, necrosis, vision abnormalities, malaise, scarring, nausea, granuloma, deeper wrinkle, and dyspnea.Reported treatments include: antibiotics, steroids, antiseptic creams, hyaluronidase, anti-inflammatories, antihistamines, needle aspiration, eye drops, radio frequency therapy, hyperbaric oxygen treatment, laser treatment, ice, massage, warm compress, analgesics, anti-virals, ultrasound therapy, excision, drainage, and surgery.".

Event Description

Healthcare professional reported injecting a patient with juvéderm voluma® xc in the cheeks.On the following day, the patient developed "bilateral abscesses on the cheeks" and pustules.Patient was treated with antibiotics, hyaluronidase and levaquin.About 10 weeks after symptoms appeared, the effected area was aspirated and cultured twice while the patient was still taking levaquin.Symptoms have improved.

Manufacturer Narrative

The events of swelling, edema, scarring, inflammation and positive for e.Coli 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, scarring and infection: "5.Precautions as with all transcutaneous procedures, dermal filler implantation carries a risk of infection.Standard precautions associated with injectable materials should be followed.B.1-year post-approval study of juvéderm voluma® xc all device/injection-related aes after repeat treatment were mild to moderate, required no action, and resolved without sequelae.Generally, device/injection-related aes were less severe after repeat treatment compared to initial/touch-up treatment, and most resolved within 3 months.Similar to the initial/touch-up treatment, 3 subjects experienced a device/injection-related ae that lasted more than 180 days, but all resolved without requiring any treatment.Device/injection-related adverse events occurring in = 1% of subjects included injection site swelling (0.6%), injection site pain (0.6%), and injection site papule (0.6%).B.Health care professional instructions 18.Patients may experience treatment site responses, which typically resolve within 2 to 4 weeks.Ice may be applied for a brief period following treatment to minimize swelling and reduce pain.".

Event Description

Additional information: patient reported being positive for e.Coli from their culture results.Patient indicated that the swelling had improved but was "is terribly scarred and it looks horrible." the healthcare professional reviewed the patient was seen approximately 2.5 weeks after the area was re-cultured and patient showed ¿improvement but still had minor areas of inflammation and edema.¿ treatment with levaquin was continued.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• 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: 6692432
• MDR Text Key: 79245341
• Report Number: 3005113652-2017-00610
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A70022(11)170120(17)180620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 94640
• Device Lot Number: VB20A70022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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: 48 YR