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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 94729JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 08/15/2017
Event Type  Injury  
Event Description
Healthcare professional later reported patient had "infiltrate red papule, pustule, abscess. ".
 
Manufacturer Narrative
Further information from the reporter regarding event details has been requested. No additional information is available at this time. The events of "nodules", "red papule", "pustule", and "abscess" 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 completed. No deviations or non-conformances noted. 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 these 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 patient was injected with. 6ml of juvéderm® volbella¿ with lidocaine in the periorbital and gabella regions, and 1ml of juvéderm® ultra 3 in the nasolabial folds and marionette lines. Eleven days post injection "nodules developed". Healthcare professional later reported patient had "[illegible] red papule, pustule, abscess. " patient was treated with clarithromycin 2 x 500mg and rifampicin 2 x 300mg for four weeks. Also ciprofloxacin 2 x 500mg. Patient received octenisept pre-injection, and fucidin acid local post-injection. Symptoms ongoing.
 
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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 Key6924674
MDR Text Key110244212
Report Number3005113652-2017-01222
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeHU
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 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number94729JR
Device Lot NumberV15LA70118
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 Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2017
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: 10/06/2017 Patient Sequence Number: 1
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