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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLLURE (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLLURE
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 07/25/2022
Event Type  Injury  
Manufacturer Narrative
The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported injecting a patient with 1 ml of juvéderm® vollure¿ xc.The patient experienced vascular occlusion was treated with 16 vials of hylenex, aspirin, doxycycline, and valacyclovir.Event status is unknown.
 
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Brand Name
VOLLURE (VOLUME UNKNOWN)
Type of Device
IMPLANT, 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
terry ingram
12331-a riata trace parkway
building 3
austin, TX 78727
8479366324
MDR Report Key15229512
MDR Text Key297947199
Report Number3005113652-2022-00513
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
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 Physician
Type of Report Initial
Report Date 08/15/2022
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK VOLLURE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2022
Initial Date FDA Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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