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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 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.
 
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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 Key8227469
MDR Text Key132398974
Report Number3005113652-2018-01838
Device Sequence Number1
Product Code LMH
UDI-Device Identifier30888628000081
UDI-Public30888628000081
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
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 Date08/03/2019
Device Catalogue Number94154
Device Lot NumberH24LA80175
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BOTOX®
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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