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 Itching Sensation (1943); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 05/19/2017

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 redness, itching, bumps, blistering, and "you could see where the filler was injected" 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 addresses the reported event(s) as follows: "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.Adverse events ¿ the most common injection site responses for juvéderm® ultra plus xc were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.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 site, allergic reaction, infection at the injection site, migration, 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.Additionally there have been reports of nodules, infection, and inflammation.¿ the onset of nodules generally varied from immediate to 2 months post injection.The treatment prescribed included nsaids, antibiotics, steroids, and hyaluronidase.In most cases nodules resolved within 1 month.¿ the onset of inflammation generally varied from the day of treatment to 1 day post injection.The treatment prescribed included antibiotics, steroids, and needle aspiration.Resolution of symptoms has been reported within 4 days.".

Event Description

Healthcare professional reported after injection in the nasolabial folds with 1 syringe of juvéderm® ultra plus xc, the patient experienced ¿redness, itching, and bumps¿ one week later.It was also noted that patient developed blistering.Symptoms were noted as being worse with exercise and in the evening hours.Healthcare professional also added that "you could see where the filler was injected." six days later, the patient was treated with hylenex.Symptoms improved after the hylenex injection and completely resolved 5 days post treatment with hylenex.Patient was taking b12, vitamin d3, fish oil, and venlafaxine concomitantly with the injection.

• 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: 6654726
• MDR Text Key: 78017443
• Report Number: 3005113652-2017-00520
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)H30LA60587(11)170116(17)180616
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Catalogue Number: 94155
• Device Lot Number: H30LA60587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• 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: 70 YR