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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Autoimmune Reaction (1733); Unspecified Infection (1930); Skin Inflammation (2443)
Event Type  Injury  
Manufacturer Narrative
Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The events of "possible infection," "blisters," and "mucous membrane pemphigoid" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling addresses the reported event(s) as follows: "warnings: injection site reactions consist mainly of short-term inflammatory symptoms starting early after treatment and lasting
=
7 days in facial wrinkles and folds, and typically last
=
14 days in the lips. Refer to the adverse events section for details. Precautions: as with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed. Adverse events: the most common injection site responses for juvéderm® ultra 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, 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 adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, 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. ".
 
Event Description
Patient reported they were injected with less than one syringe of juvéderm® ultra xc in the lips and "sides of the lips. " about a week after injection patient developed "possible infection" and blisters at the injection areas. Patient additionally noted the blisters are "all on the inside of the mouth" and there is nothing on the outside of the mouth. The patient was prescribed bactrim and metronidazole by a dentist. The patient was also prescribed tacrolimus and a "magic mouthwash" by a periodontist who believes the patient is suffering from mucous membrane pemphigoid. The patient indicated they are going to have an allergy test administered soon to rule out an allergy to the juvéderm®. Symptoms are ongoing.
 
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Brand NameJUVEDERM ULTRA XC TSK US
Type of DeviceIMPLANT, 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 Key7152961
MDR Text Key96002434
Report Number3005113652-2017-01713
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/20/2018
Device Catalogue Number94154
Device Lot NumberH24LA70234
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2017
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: 12/28/2017 Patient Sequence Number: 1
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