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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) VOLIFT (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLIFT
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Necrosis (1971); Vascular System (Circulation), Impaired (2572)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative
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. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reports 2cc juvederm vista volift injection in the wrinkle of the forehead. The same day, pain presented and it was so painful that patient cannot even wash [the] face. Patient did not contact institution at that time, but visited 4 days later. The skin color changed into purple (location- left half of forehead) and partial necrosis was confirmed. Immediately dissolved product via the hyaluronidase. Patient visited institution again the following day and 6 days after that, the condition improved constantly. The symptom area remained red and itchy, so patient was treated with oral medicine continually. Antibiotic, nsaids, gentamicin, hyaluronidase provided as treatment. Symptoms ongoing.
 
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Brand NameVOLIFT (VOLUME UNKNOWN)
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 Key10502550
MDR Text Key205947672
Report Number3005113652-2020-00516
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLIFT
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 Received08/14/2020
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

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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