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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 Problem Vascular System (Circulation), Impaired (2572)
Event Date 10/27/2020
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 using a cannula to inject a juvéderm® volift ¿ with lidocaine in the bilateral nasogenian groove/nasolabial fold region. Positive aspiration denied. Hcp injected product to the right nasogenian groove and noticed a color change on the right side when moving to the left side. Hcp had doubts as to whether it would be an arterial obstruction. The procedure continued, applying juvéderm® volift¿ with lidocaine to the lips. When the application on the lips was finished, livedo in the supralabial, perinasal and right malar regions was already quite evident. The patient denied pain at any time. Initially, 1 ampoule of reductonidase (1500 rtu) was applied. In the following hours, hcp injected 2 more ampoules of 2000utr from biomethyl, without significant improvement. Patient received aas 500mg and prednisone 40mg. Patient was evaluated by a radiologist, who has no experience with fillers and did not identify arterial or venous obstruction on ultrasound examination. Hcp also requested an evaluation by a vascular physician, who indicated associating vasogard (cilostazol). Two days post injection, physician continues to perform hyaluronidase applications and the patient continues with asa, prednisone, massage, warm compresses and daily hyperbaric chamber sessions. Another specialist is consulting on the case for treatment. One week after the obstruction occurred, injector noted that patient's issue is evolving well.
 
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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 Key10880005
MDR Text Key217701942
Report Number3005113652-2020-00720
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeBR
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 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received10/27/2020
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: 11/20/2020 Patient Sequence Number: 1
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