MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

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

Patient Problems Erythema (1840); Rash (2033); Skin Irritation (2076)

Event Date 11/13/2018

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 "redness and swelling, blisters, severe itching, feel like skin was on fire, looked like contact dermatitis--blisters and erythema" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been initiated.If any deviations or non-conformances are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported within 3 days of injection with 1cc of juvéderm® ultra xc into the nasolabial folds, lip lines, corner of mouth, and mental crease, the patients the skin on the nasolabial folds developed redness and swelling which progressed to blisters.Patient experienced severe itching, and felt like their skin was on fire.Clinically looked like contact dermatitis -blisters and erythema in nasolabial folds and corners of mouth.The injector was concerned with a possible allergy to the topical anesthetic, because the patient has a history of neosporin allergy.The patient was concomitantly injected with 45 units of botox in the glabella and lateral canthus.Patient was placed on prednisone 30mg for 5 days and then 20mg as well as topical mometasone.7 days later epidermal skin better but dermal induration worse-now whole perioral area with some nodules and dusky erythema.The injector now believed the reaction was due to the juvéderm®.Prednisone increased to 60mg for 5 days then 40mg for 5 days then 10mg for 5 days.17 days post injection patient was improved but still felt ¿pressure over their sinuses¿ and felt their skin was very sensitive-burning.The patient had some papules which resembled rosacea, and the topical mometasone was stopped, and instead started on doxycycline.The patient received injections of hylenex 75 units, and kenalog 2.5mg/cc in the remaining indurated area.The patient was seen 3 weeks post injection and symptoms had resolved.

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 8227469
• MDR Text Key: 132398974
• Report Number: 3005113652-2018-01838
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

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: 08/03/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2018
• 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: BOTOX®
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR