MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM ULTRA XC/LIDO

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

Patient Problems Edema (1820); Erythema (1840)

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 swelling and redness 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: "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.Method of use ¿ posology.Juvéderm ultra¿ xc is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.Warnings check the expiry date on the product label.".

Event Description

Healthcare professional reported treating a patient that was injected by another physician to the mid cheek and lateral epicanthus with 3 syringes of juvéderm ultra¿ xc that had expired in (b)(6)2010.Sometime after the injection, the patient developed "persistent swelling and redness" at the site of injection in addition to areas that were not injected.The patient had "severe edema in the eye area." patient also had edema on the upper eye lid as well as the glabellar region where the patient had not been injected.Patient has been treated with hyaluronidase and there was success with "breaking down the product under the eyes." a biopsy of the area under the eye was done and the histology report confirmed there being hyaluronic acid.The patient had also previously been injected with expired botox® in the glabella, canthus and frontalis.It was also noted that if the symptoms were to continue, it could affect the patient's vision as the patient's eyes were becoming swollen to the point the eyes were closing.The symptoms in the under eye area have resolved after treatment with hyaluronidase, but swelling in the upper lid and glabella is ongoing and those areas have not been treated with hyaluronidase.

• Brand Name: JUVEDERM ULTRA XC/LIDO (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: 6769048
• MDR Text Key: 81898632
• Report Number: 3005113652-2017-00781
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM ULTRA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention