MAUDE Adverse Event Report: Q-MED AB / GALDERMA LABORATORIES, LP. RESTYLANE; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Swelling (2091); Reaction (2414)

Event Date 07/08/2018

Event Type  Injury  

Event Description

I was injected by restylane in eye area by two different medical professions.I had and still suffer from swollen eye.I have been on prednisone for over a year to help open my left eye and stop the swelling but things are getting bad by day.I was not informed about restylane horrible side effects and i am still suffering emotionally and professionally due to the way i look (like alien) because of this injection, i spent the last year visiting tens of drs from all professions (allergists, eye surgeons, primary care drs, arthritis to find out what is wrong with my eye and found out by coincident that what i am suffering from is a delayed side effect from restylane.

• Brand Name: RESTYLANE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED AB / GALDERMA LABORATORIES, LP.
• MDR Report Key: 8794682
• MDR Text Key: 151492075
• Report Number: MW5088177
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 77