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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Skin Discoloration (2074); Skin Inflammation (2443)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
(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 bruising, discoloration, reddening and superficial blisters are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling for the reported events of skin inflammation, skin discoloration, bruising and erythema: 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. Haematomas. 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
Healthcare professional reported injecting a patient with juvéderm volbella with lidocaine in the upper lip. Prior to the injection, the patient was given an infraorbital nerve block. Four days later, the patient informed the doctor of bruising and discoloration that started the day after the injection. Symptoms improved over a few days but then there was noted reddening of the left upper lip an cheek. The patient was treated with hyalase, augmentin, aspirin and g7n paste. It was noted that there were superficial blisters. Symptoms are 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 Key7455365
MDR Text Key106331362
Report Number3005113652-2018-00418
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeSN
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 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number94731RX
Device Lot NumberV15LA70423
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 Received03/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2017
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: 04/24/2018 Patient Sequence Number: 1
Treatment
INFRAORBITAL NERVE BLOCK
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