MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRAPLUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)

Event Date 07/11/2018

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 purple, livedo, occlusion, ecchymosis, hyperemia, blister, lesions, pain, and crusts are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: contra-indications do not inject 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. 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 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 that a patient was injected in the nasogenian groove with juvéderm ultra plus¿ on each side. The injecting site turned purple and healthcare professional thought the patient had either ecchymosis or an occlusion as the injected area, extending to the nasal region, had the appearance of livedo, hyperemia, blister/ crusts, and ecchymosis. The patient also experienced pain upon palpation. Treatment with hyaluronidase was given within 2 days of the injection and improvements were noticed with the lesions and pain.

• Brand Name: JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)
• Type of Device: IMPLANT, 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 Key: 7767172
• MDR Text Key: 116553130
• Report Number: 3005113652-2018-00995
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK JUVEDERM ULTRAPLUS
• 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 Received: 07/12/2018
• 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