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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94703RX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Vascular System (Circulation), Impaired (2572)
Event Date 05/06/2020
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. 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 reports that a patient was injected with 1 ml juvéderm¿ volift¿ with lidocaine. Patient informed that there was no adverse event after this injection. Approximately 60 days later, an additional 2 ml of juvéderm¿ volift¿ with lidocaine was applied. Product injected into the lips. Patient developed vascular occlusion and necrosis. Change in color and pain noticed between 8-10 hours after the injection, but patient went to bed to sleep. The next morning, patient contacted the physician and suspected a vascular event based upon photos seen on the internet. Physician observed lightness or marbling skin in the territories irrigated by the superior labial, inferior labial, lateral of nose and even the angular arteries, the mucosa was untouched at the time. Ulcerations observed at the level of the lower lip mucosa via pictures previously taken by patient. Patient states ¿it didn't hurt but it has a weird feeling. " event was considered a ¿tissue integrity threat. " hyaluronidase provided after 2 days. Aspirin, warm compresses,cephalexin, sildenafil 25 mg and an injectable corticosteroid also provided. Symptoms resolved 2. 5 weeks post onset. This is the same event and the same patient reported under mdr id# 3005113652-2020-00305 (allergan complaint #(b)(4)). This mdr is being submitted for the second injection of juvéderm¿ volift¿ with lidocaine.
 
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Brand NameVOLIFT WITH LIDOCAINE
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 Key10158059
MDR Text Key195256574
Report Number3005113652-2020-00306
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeAR
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,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number94703RX
Device Lot NumberV17LA90497
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 Received06/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2019
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: 06/16/2020 Patient Sequence Number: 1
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