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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL INC. BELLAFILL; DERMAL IMPLANT
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SUNEVA MEDICAL INC. BELLAFILL; DERMAL IMPLANT Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Hair Loss (1877); Pain (1994); Tissue Damage (2104); Deformity/ Disfigurement (2360)
Event Date 12/15/2016
Event Type  Injury  
Event Description
Caller called to report that since she has had novathreads and bellafill implanted that she has had pain, facial disfigurement, lost hair on her head, eyebrows, eyelashes and felt movement of novathreads throughout her body.Reporter states that it feels like worms are moving in her body and that the threads are protruding out of her skin.On a follow up appointment with her doctor, the doctor cut the excess suture and told her that she could not be experiencing any her those side effects.She reports that she feels the threads have migrated into chest, back,legs, and her eyes causing her knot over her eye and for her cornea to split.She states that when the outside temperature is hot that her skin feels gluey, turns black and that granule sugary substance comes out of her.Reporter states that she can't find anyone to give her treatment for dermal filler and threads in her state and that she will have to travel to another state to seek treatment.
 
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Brand Name
BELLAFILL
Type of Device
DERMAL IMPLANT
Manufacturer (Section D)
SUNEVA MEDICAL INC.
MDR Report Key7154508
MDR Text Key96147290
Report NumberMW5074295
Device Sequence Number2
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 12/28/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age61 YR
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