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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 95661
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 01/21/2022
Event Type  Injury  
Manufacturer Narrative
Suspect product: lot number 918. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The event of "occlusion" 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 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported injecting a patient in the lips with juvéderm vollure¿ xc. The patient experienced ¿an occlusion¿ at the injection site that day. The patient was treated the same day with hylenex (150 u), aspirin 325 daily, prednisone taper 70 mg day 1 which goes down 10 mg each day for four days, massage, warm compress, tapping, mls laser, keflex prescription given on day 5. On day 5 of treatment, it was noted "mild color difference right to left. " the event is ongoing.
 
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Brand NameJUVEDERM VOLLURE XC 2X1 ML
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 Key13419391
MDR Text Key285635307
Report Number3005113652-2022-00055
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number95661
Device Lot NumberV17LB10513
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2021
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: 02/01/2022 Patient Sequence Number: 1
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