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 Erythema (1840); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The events of "vascular occlusion, erythema, pustules, bruise, scar, vision changes and concern over procedure" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event. Device labeling: adverse events: table 1 and 2: treatment site responses by maximum severity and duration occurring in > 5% of subjects after initial treatment (n
=
265). Possible treatment site responses include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. 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%). Instructions for use: 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. Within the first 24 hours, patients should avoid strenuous exercise and extensive sun or heat exposure. Exposure to any of the above may cause temporary redness, swelling, and/or itching at the treatment sites 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

Treating healthcare professional (hcp) reported patient was injected with juvéderm® voluma® xc. Patient presented with erythema and pustules. Patient returned to injecting hcp, who said "it was a bruise", and refused to treat it. Patient later experienced "vision changes, which fortunately came back". Patient has been left with scarring. Patient later indicated they were "very concerned with what product was used". No treatment was provided. Symptoms ongoing.

Event Description

Further follow up revealed patient ¿developed bruising [a] few hours after treatment¿ and vision abnormalities were not reported by the patient. Per healthcare professional, ¿patient left office with no cheek swelling or discoloration. ¿.

Manufacturer Narrative

A review of the device history record has been initiated. If any deviations or non-conformances are found, a supplemental medwatch will be submitted.

• 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
• MDR Report Key: 8103537
• MDR Text Key: 128387954
• Report Number: 3005113652-2018-01581
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/24/2020
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80554
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/26/2018 Patient Sequence Number: 1