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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94155
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Anxiety (2328); Depression (2361)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
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 is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
 
Event Description
Health professional (hcp) reported concomitantly injecting a patient with 1 syringe of juvéderm® ultra plus xc, 1 syringe of juvéderm vollure¿ xc, and 18 units of botox®.3 days later, the patient reported experiencing ¿anxiety, headache, labile emotional state and depression.¿ the patient went to the emergency room and was treated with unspecified anxiety medications and discharged.The hcp added that ¿the patient doesn¿t want to get dependent on the medications¿.The patient reported being ¿okay when working¿, but ¿as soon as [the patient] leaves to get in [the] car, [the patient] gets emotional and wants the fillers out.¿ the patient has no history of anxiety or depression.The symptoms have not resolved.This is the same event and the same patient reported under mdr id # 3005113652-2019-00530 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, juvéderm® ultra plus xc, also a device manufactured by allergan.
 
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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
michelle burgess
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key8782020
MDR Text Key150819351
Report Number3005113652-2019-00529
Device Sequence Number1
Product Code LMH
UDI-Device Identifier30888628000111
UDI-Public30888628000111
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 07/11/2019
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 Date12/01/2019
Device Catalogue Number94155
Device Lot NumberH30LA80476
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/14/2019
Initial Date FDA Received07/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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