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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 09/02/2020
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. 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. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Health professional reported injecting a patient in the lips with one syringe of juvéderm® ultra xc and in the chin with one syringe of juvéderm voluma® xc. The patient experienced ¿vascular occlusion¿ in the lips that same day. The patient was treated with 300 cc of hylenex and again with another 825 cc. The patient was treated with hot towels and massaged as well. The event was reported as ¿cleared up. ¿.
 
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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 Key10643276
MDR Text Key210372307
Report Number3005113652-2020-00580
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
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2021
Device Catalogue Number94154
Device Lot NumberH24LB00040
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 Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2020
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: 10/07/2020 Patient Sequence Number: 1
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