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 Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction, Injection Site (2442)

Event Date 10/02/2018

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 event of "allergic reaction, skin rash, redness, bit swollen, and pulsing" 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: 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%).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.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.

Event Description

Healthcare professional (hcp) reported that a patient was injected in the cheeks with one syringe of juvéderm voluma® xc.Hcp reported the patient is experiencing an allergic reaction and has "a skin rash, redness, and is a bit swollen." patient is also experiencing "pulsing." the adverse events are all occurring in the injection area.Patient was prescribed with medrol dose pack, acyclovir, augmentin, triamcinolone, and prednisone.Symptoms eventually resolved.

Manufacturer Narrative

Additional information: a review of the device history record has been completed.No deviations or non-conformances noted.

Event Description

Healthcare professional (hcp) reported that a patient was injected in the cheeks with one syringe of juvéderm voluma® xc.Hcp reported the patient is experiencing an allergic reaction and has "a skin rash, redness, and is a bit swollen." patient is also experiencing "pulsing." the adverse events are all occurring in the injection area.Patient was prescribed with medrol dose pack, acyclovir, augmentin, triamcinolone, and prednisone.Symptoms eventually resolved.

• 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: 8116301
• MDR Text Key: 128865693
• Report Number: 3005113652-2018-01631
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: 30888628000012
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: 08/14/2019
• Device Catalogue Number: 94640
• Device Lot Number: VB20A80193
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOTOX®
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR