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

Catalog Number 94155

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

Patient Problems Edema (1820); Erythema (1840); Rash (2033)

Event Date 09/05/2017

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. A review of the device history record has been completed. No deviations or non-conformances noted. Device labeling: 4. Warnings injection procedure reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
7 days¿ duration. Refer to the adverse events section for details. 5. Precautions as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. The safety in patients with known susceptibility to keloid formation, hypertrophic scarring and pigmentation disorders has not been studied. 6. Adverse events table 1. And 2. Injection site responses by maximum severity and duration (number/% of subject nasolabial folds [nlfs]). Possible treatment site responses include: redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration. Postmarket surveillance the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, which were not observed in the clinical trials; this includes reports received globally from all sources including scientific journals and voluntary reports. All adverse events obtained through postmarket surveillance with a frequency of 5 or more events are listed in order of prevalence: lack or loss of correction, inflammatory reaction at the injection site, skin rash, bleeding at the injection paresthesia, vascular occlusion, necrosis at the injection site, abscess at the injection site, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma. In many cases, the symptoms resolved without any treatment. Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress. Inflammatory reaction at the injection site, mostly a nonserious event, has been reported in association with edema, erythema, ecchymosis, pruritus, induration, pain, nodule, blister, abscess, and infection. Time to onset ranged from 1 day to 4 months post juvéderm® ultra plus injection, and outcome ranged from resolved to ongoing at last contact. Interventions prescribed by the health care professionals included topical steroidal cream, oral steroids, and antibiotics. Additional treatment noted was a needle aspiration for drainage of an abscess. Serious adverse events have infrequently been reported for juvéderm® ultra plus (reported with a frequency of 5 or more). The most commonly reported serious adverse events were edema, erythema, ecchymosis, and pain. The onset of edema, erythema, and pain generally varied from immediate to 2 months post injection. The treatment prescribed included nsaids, anti-histamines, antibiotics, steroids, and hyaluronidase. In most cases, the reported events resolved within a few days to 5 weeks. The onset of ecchymosis generally varied from immediate to 1 day post injection. The treatment prescribed included nsaids, anti-histamines, antibiotics, steroids, and hyaluronidase. In most cases ecchymosis resolved within a few days to 6 weeks.

Event Description

Healthcare professional reported that a patient was injected in the lips with 1 cc of juvéderm® ultra plus xc and immediately developed a rash around the injection site in the perioral area. The area was red, swollen, papule, not pustular, no blister, and not cellulitis. Treatment with a topical hydrocortisone cream 2. 5% was given with no resolution. The event decreased but upon discontinuation the reaction returned. A medrol dose pack was prescribed approximately 1. 5 months later and symptoms resolved but returned after completion of treatment. Two weeks later, another topical steroid cream was given but patient could not tolerate due to ¿severe dryness¿ and treatment was discontinued. At the same time, an oral methylprednisolone taper was also given and symptoms returned after completion of treatment. Two weeks after the previous treatment, keflex was prescribed for paronychia and the patient¿s rash subsided. Another course of keflex was started 9 days after the first course began. The patient took keflex for approximately 2 months and symptoms resolved and patient then reported ¿hyperpigmentation. ¿ patient¿s symptoms were completely resolved when patient was seen for a ¿botox® injection¿ 3 months following the start of the 2nd round of keflex.

• Brand Name: JUVEDERM ULTRA PLUS 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: 7503729
• MDR Text Key: 107895800
• Report Number: 3005113652-2018-00486
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/23/2018
• Device Catalogue Number: 94155
• Device Lot Number: H30LA70305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/10/2018 Patient Sequence Number: 1