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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVANCE THERAPEUTICS, INC. RHA3 IMPLANT, DERMAL, FOR AESTHETIC USE

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REVANCE THERAPEUTICS, INC. RHA3 IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problems Material Too Rigid or Stiff (1544); Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Deformity/ Disfigurement (2360); Swelling/ Edema (4577)
Event Date 05/31/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, i received revance rha3 fillers in my marionette lines. (b)(6) weekend, those fillers became hard, red and swollen. My face is deformed. I visited my doctor (b)(6) and he contacted revance. I was put on steroids for a week with no change. On (b)(6), when i was crying to my sister about how i wanted this junk out of my face, she recommended i get it dissolved. (she is an event-planner and is not in the medical field). I told my doctor this was my plan and he said revance said that was fine. (why was this not recommended in the first place?) on (b)(6), i visited my doctor and had my first round of hyaluronidase. During which i cried, then cried in my car for 15 min. The fillers moved around, stayed hard and swollen and red. There was some reduction but slight. (b)(6), another visit and more hyaluronidase. Small improvement. The area is still red and swollen. (b)(6), more hyaluronidase. Today, the area is still red, hard and swollen. Fda safety report id # (b)(4).
 
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Brand NameRHA3
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
REVANCE THERAPEUTICS, INC.
7555 gateway blvd.
newark CA 94560
MDR Report Key12108632
MDR Text Key260220301
Report NumberMW5102280
Device Sequence Number1
Product Code LMH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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: 07/01/2021 Patient Sequence Number: 1
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