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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94155ED
Device Problems Gel Leak (1267); Detachment of Device or Device Component (2907)
Patient Problems Skin Irritation (2076); Skin Inflammation (2443); Vascular System (Circulation), Impaired (2572)
Event Date 08/10/2018
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 lumps, redness, pain, swelling, blistering, sensitive, blocked feeling, pus and vascular event 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 initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Device labeling: contra-indications: do not inject juvéderm® voluma® with lidocaine into the blood vessels (intravascular). Intravascular injection may lead to embolisation, occlusion of the vessels, ischaemia 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 paraesthesia, occurring after the injection. These reactions may last for a week. 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 ischaemia or cerebral haemorrhage, 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 injecting a patient with juvéderm ultra plus xc in the nasolabial folds and lips. A 25g cannula was used to inject the product, but during the injection on the 2nd side (left): the cannula started leaking. An attempt was made to screw the cannula on tighter, but the cannula would not properly lock onto the syringe and the rest of the procedure was done with the packaged needle. About 6 hours after the injection, the patient developed redness, pain, swelling and blistering in the left cheek. Patient also mentioned having the inside of their left nostril feel sensitive and blocked soon after the injections. There was also small lumps and redness forming towards the eye after the injection. It was 3 days after the injection the healthcare professional would be notified of these symptoms. Patient reviewed was reviewed and it was noted that redness and pus had formed. Patient had developed a vascular occlusion on the left side. Patient was treated with hylase on a daily basis as well as platelet rich plasma treatment. Patient was reviewed again a week later and he redness had improved and no necrosis of the skin was seen. The blisters, pain and swelling had subsided. Symptoms had been improving daily.
 
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Brand NameJUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC)
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 Key7866248
MDR Text Key119878997
Report Number3005113652-2018-01167
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeAS
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 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number94155ED
Device Lot NumberH30LA80129
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 Received08/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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