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

Catalog Number JUVEDERM ULTRA XC/LIDO (VOLUME

Device Problem No Apparent Adverse Event (3189)

Patient Problems Edema (1820); Skin Discoloration (2074)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Reported events of "bilateral lower eyelid swelling and discoloration of 4 months duration" found in one patient in the following journal article: "delayed superficial migration of retained hyaluronic acid years following periocular injection," ophthalmic plastic and reconstructive surgery.Date of publication: (b)(6) 2015.Authors noted, "no improvement was seen with atrial of weekly intravenous methylprednisolone 250 mg for 6 weeks." authors noted that symptoms resolved "after surgical debulking, 2 injections of hyaluronidase (50 and 60 units) resolved the swelling." in follow-up, the author noted the device "did not absorb as intended" and that the device was explanted.

Manufacturer Narrative

• Brand Name: JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN; pringy ; FR
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: krista alvarado ; 301 w howard ln; ste 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 4788066
• MDR Text Key: 20018982
• Report Number: 3005113652-2015-00252
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JUVEDERM ULTRA XC/LIDO (VOLUME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/19/2015
• 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 Sequence Number: 1
• Patient Age: 53 YR