• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Ecchymosis (1818); Ischemia (1942); Vascular System (Circulation), Impaired (2572)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
Allergan has initiated an investigation into this late report. See capa (b)(4).
 
Event Description
Additional information: healthcare professional believes they "missed the site of injection" and injected into a vessel, which "caused a hematoma that took time to go to surface. " physician informs "there is no complaint about the product. " symptoms improved 1 to 2 days later.
 
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 erythema, ecchymosis, purple area, edema, ischemia, and occlusion 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 events as follows: contra-indications ¿ "do not inject juvéderm® volbella¿ with lidocaine into the eyelids. The application of juvéderm® volbella¿ with lidocaine in the bags under the eyes is reserved to specialists specifically trained in this technique and having a sound knowledge of the physiology for this particular area. ¿ do not inject into the blood vessels (intravascular). Intravascular injection may lead to embolization, occlusion of the vessels, ischemia or infarction. " 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). ¿ 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. ¿ patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible. The medical practitioner should use an appropriate treatment. " method of use ¿ posology ¿ "after needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular. ".
 
Event Description
Healthcare professional reported injecting theirself to the malar eyelid groove with 0. 2ml of juvéderm® volbella¿ with lidocaine. Right after injection physician noticed a small area of "erythema/ecchymosis" and decided to perform radiofrequency on the injected area that day. After 2 sessions of radiofrequency on the eyelid area, physician noticed increase of the purple area and local edema. Physician refers to the event as "suspicious ischemia" and believes they are with occlusion. A company representative noted "this event is related to a probable ecchymosis after injection and increased hematoma and local edema due to radiofrequency heat. " symptoms are ongoing, though the next day the area was improved.
 
Manufacturer Narrative
Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these reactions: all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications. The extrusion force value shows an expected consistency of the product. The sterilization cycle is registered as conforming.
 
Event Description
Healthcare professional reported injecting theirself to the malar eyelid groove with 0. 2ml of juvéderm® volbella¿ with lidocaine. Right after injection physician noticed a small area of "erythema/ecchymosis" and decided to perform radiofrequency on the injected area that day. After 2 sessions of radiofrequency on the eyelid area, physician noticed increase of the purple area and local edema. Physician refers to the event as "suspicious ischemia" and believes they are with occlusion. A company representative noted "this event is related to a probable ecchymosis after injection and increased hematoma and local edema due to radiofrequency heat. " symptoms are ongoing, though the next day the area was improved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6540066
MDR Text Key101522513
Report Number3005113652-2017-00302
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Catalogue Number94731RX
Device Lot NumberV15LA50234
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-