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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA XC (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154ED
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 05/17/2021
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 event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported that patient was injected with juvéderm ultra® xc. Patient reported no issue with the healing process after and was happy with the aesthetic outcome. Three months and a week later, patient noticed a blister develop. Five days later, ¿the blister popped and [patient] noticed a thick fluid/material came out that [patient] described as being like filler, with no other liquid or blister contents. ¿ five days later, patient came into the office and advised that the area healed well thereafter and that there was no further issue and described nothing that sounded like infection. The area that [patient] reports the blister was in the inside of the lower left lip, approximately 4-6mm from the wet/dry border. The area [hcp] observed was not part of the original treatment area and on palpation [hcp] could feel no filler or signs of migration near the blister area. The [patient] has been fit and well and reports no periods in between treatment and now of illness. The area has not been red, hot, inflamed or painful for the [patient] and no signs of trauma in the surrounding areas of the mouth, gums of tongue were observed. [hcp] recommended the client keep the area as clean as possible.
 
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Brand NameJUVEDERM ULTRA XC (1 ML COC)
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy
Manufacturer Contact
chris sprague
12331-a riata trace parkway
building 3
austin, TX 78727
8479375615
MDR Report Key12089166
MDR Text Key266171027
Report Number3005113652-2021-03060
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeNZ
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number94154ED
Device Lot NumberH24LB00372
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 Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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