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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 Rash (2033); Skin Discoloration (2074)
Event Date 11/12/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: describe event or problem, evaluation codes. The event of "purple" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Device labeling addresses the reported event(s) as follows: "undesirable effects ¿ staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect). ".
 
Event Description
Further follow up with the healthcare professional revealed the patient was evaluated by a physician intern and the "presumptive" diagnosis was ¿purple. ¿ healthcare professional did not ¿find a relationship with juvéderm® volift¿ with lidocaine¿ and suspects it was a coincidence.
 
Manufacturer Narrative
A review of the device history record has been completed. No deviations or non-conformances noted. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event(s) as follows: "undesirable effects the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc. ) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection. These reactions may last for a week. In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of theses tissues. Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended. ".
 
Event Description
Company representative reported on behalf of the healthcare professional who noted after injection with juvéderm® volift¿ with lidocaine in the upper and lower lip, the patient developed a skin rash in the face, thorax, abdomen, inferior and superior limbs the next day. Patient received unspecified treatment. Symptoms have attenuated.
 
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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
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key7082433
MDR Text Key225039947
Report Number3005113652-2017-01566
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCO
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 01/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number94703RX
Device Lot NumberV17LA70079
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 Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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