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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL IMPLANT, DERMAL, FOR AESTHETIC USE

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SUNEVA MEDICAL, INC. BELLAFILL IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Date 12/01/2021
Event Type  Injury  
Event Description
Bellafill injection has caused me to experience continued inflammatory response, inclusive of swelling and redness of skin. Given it's permanent nature, once placed under skin, there is no antidote to reverse. It is marketed as a 5 year filler but by nature of its composition, it is permanent. This is very deceiving for the consumer. There are hundreds of patients suffering for unsightly inflammatory reactions, granulomas and nodules. The medical community at large does not know how to manage these adverse events. Fda safety report id# (b)(4).
 
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Brand NameBELLAFILL
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
MDR Report Key13425112
MDR Text Key285013484
Report NumberMW5107137
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

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