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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA LABORATORIES, L.P. RESTYLANE LYFT AND RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE
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GALDERMA LABORATORIES, L.P. RESTYLANE LYFT AND RESTYLANE DEFYNE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Swelling (2091)
Event Date 02/21/2020
Event Type  Injury  
Event Description
I was getting fillers for facial wrinkles. I had reported that (b)(6) was the only filler that was appropriate but doctor says there is no documentation of that in my health record. I was given restylane fillers at the time. By the end of september i had one large bump on the left cheek and smaller ones around my face. I saw a dermatologist who sent me to a plastic surgeon. The dermatologist said it was a lipoma. The plastic surgeon felt it and said he did not think it was a lipoma and did and excision: lipoma vs. Epidermoid inclusion cyst on left inferior medial malaria cheek. Results: foreign body giant cell reaction to filler material. No malignancy seen. I then saw a dermatologist for second opinion who had to inject several units to remove other restylane bumps.
 
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Brand NameRESTYLANE LYFT AND RESTYLANE DEFYNE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA LABORATORIES, L.P.
MDR Report Key11201404
MDR Text Key227989233
Report NumberMW5098887
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
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

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