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U.S. Department of Health and Human Services

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

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Q-MED AB / GALDERMA LABORATORIES, LP. RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameRESTYLANE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
Q-MED AB / GALDERMA LABORATORIES, LP.
MDR Report Key8794682
MDR Text Key151492075
Report NumberMW5088177
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/15/2019 Patient Sequence Number: 1
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