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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 Problem Urinary Tract Infection (2120)
Event Date 10/15/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant therapies: juvéderm voluma® xc. The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was discarded. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. The event of urinary tract infection, deemed not related to the device, is considered an unexpected adverse drug experience.
 
Event Description
Health professional reported injecting a patient in the cheeks with 1 cc of juvéderm voluma® xc and in the lips and nasolabial folds with 1 cc of juvéderm® ultra xc. The patient experienced a ¿nodule¿ in the right cheek and returned to the office a month after injection where ¿nodules and edema¿ were confirmed. The patient was treated with 5fu 50 ml and a steroid pack. The patient returned a week later with more ¿nodules¿ in the right cheek. The patient was treated 150 ml of hylenex, antibiotics, and a steroid injection. Two weeks later, the patient was treated with 100 ml of hylenex. The patient was currently on an antibiotic for a non-device related urinary tract infection. Three weeks later, the patient reported the nodules were worsening in the right cheek and ¿facial palsy (not related to the device)" on the right side. The patient has a previous injection in the marionette lines with juvéderm vollure¿ xc and experienced ¿an infection with an abscess¿ that had to be drained. The event is ongoing. This is the same event and the same patient reported under mdr id# 3005113652-2020-00785 (allergan complaint # (b)(4)) and mdr id# 3005113652-2020-00783 (allergan complaint # (b)(4)). This mdr is being submitted for the second suspect product, juvéderm® ultra xc.
 
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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
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key11043565
MDR Text Key222645460
Report Number3005113652-2020-00782
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/17/2020
Device Catalogue Number94154
Device Lot NumberH24LA80721
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 Received01/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2018
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: 12/20/2020 Patient Sequence Number: 1
Treatment
ENBREL, STEROIDS
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