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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) UNK VOLBELLA IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number UNK VOLBELLA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Rash (2033)
Event Date 05/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Further information from the reporter regarding event, patient, or product details has been requested. No additional information is available at this time. The events of erythema, rubbish, rash, redness, tenderness, and infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. 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: ¿ 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.
 
Event Description
Healthcare professional reported patient was injected to the frontal area with juvéderm® volbella¿ with lidocaine. Prior to injection patient was pretreated with local anesthetic and after injection ice was given. That same day patient developed erythema, rubbish, rash, and widespread redness and tenderness at the injection site. Patient was treated with hyaluronidase, nifedipine, pentoxyfilline, coraspin, and local and systemic antibiotic. Symptoms resolved after 15 days. A company healthcare professional has assessed the event as an infection.
 
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Brand NameUNK VOLBELLA
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 Key6817961
MDR Text Key83543239
Report Number3005113652-2017-00874
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeTU
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 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK VOLBELLA
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 Received08/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/24/2017 Patient Sequence Number: 1
Treatment
PRETREATMENT: LOCAL ANESTHETIC, POSTTREATMENT: ICE
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