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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 94201JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 12/15/2017
Event Type  Injury  
Manufacturer Narrative
Further information from the reporter regarding event details has been requested. No additional information is available at this time. The events of granuloma and dermatitis are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. 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. Device labeling addresses the reported event(s) as follows: precautions for use; as a matter of general principle, injection of a medical device is associated with a risk of infection. Standard precautions associated with injectable materials shall be followed. 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: induration or nodules at the injection site. Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke, blanching of the skin or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur. Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported. It is therefore advisable to take these potential risks into account.
 
Event Description
Healthcare professional reported patient was injected with 2ml of juvéderm® volift¿ with lidocaine in the nasolabial folds and mouth corners. Seven months later patient developed "perioral dermatitis". One month later patient developed "granuloma formation" on mentolabial folds. Patient was treated on three occasions with hylase. Symptoms ongoing. No noted biopsy has been performed to confirm the reported granuloma.
 
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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 Key7325999
MDR Text Key101963008
Report Number3005113652-2018-00230
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeGM
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 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number94201JR
Device Lot NumberV17LA70075
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 Received02/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2017
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: 03/08/2018 Patient Sequence Number: 1
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