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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94731RX
Device Problem Migration (4003)
Patient Problems Cyst(s) (1800); Inflammation (1932); Skin Irritation (2076)
Event Date 12/31/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: juvéderm¿ voluma¿ with lidocaine. (b)(4). Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of edema, nodule, nodule migration which looked like a "chalazion," and granuloma due to probably migration of product. Are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 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. 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 that a patient was injected in the dark circles with juvéderm® volbella¿ with lidocaine, in the malar and ck1, 2, and 3 with juvéderm® volift¿ with lidocaine and juvéderm¿ voluma¿ with lidocaine. Post treatment included ice. About one month later, the patient developed edema below the eyelid. Then, a nodule developed on the lower border of eyelid, which migrated and looked like a ¿chalazion. ¿ healthcare professional felt a granuloma was present 3 months following injection. Lower eyelid nodulation was also reported and treatment with a saline solution/lidocaine injection and massage was given 5. 5 months following first sign of edema. Ten days after treatment, healthcare professional assessed as lower eyelid nodule, suggestive of granuloma, due to probable migration of the product. After the saline/lidocaine injection, product migrated to the eyelid border. Symptoms are ongoing. Healthcare professional feels the event caused a permanent lesion and surgical intervention may be necessary. Patient plans to have plastic surgery due to dissatisfaction with results of the event. It was reported that the patient is sad about the situation. This is the same event and the same patient reported under mdr id #3005113652-2018-00851 ((b)(4)) and mdr id #3005113652-2018-00852 ((b)(4). This is the first mdr submitted for the first suspected product, juvéderm volbella with lidocaine.
 
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Brand NameVOLBELLA 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 Key7687334
MDR Text Key113961409
Report Number3005113652-2018-00850
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,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number94731RX
Device Lot NumberV15LA60371
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 Received07/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2016
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: 07/13/2018 Patient Sequence Number: 1
Treatment
JUVÉDERM® VOLIFT¿ WITH LIDOCAINE, ICE
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