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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE
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SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Model Number GBF0508
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Tooth Fracture (2428); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Patient states her teeth are falling out (9 so far) related to a nova threads procedure that occurred at the same time as bellafill dermal filler injection.In (b)(6) 2016.Patient also relays she was told by a different doctor that the threads are pushing the bellafill around her body.The name of the doctor who told her this is unknown at this time.The patient believes there is product coming out of her feet, toes, fingers, fingertips, and that it's in her mouth now.The patient states she has reported her issues to the makers of the pdo threads, nova threads, but received no help and is now contacting suneva.Background: patient had previously called suneva in (b)(6) 2017 for lumps in her face.Her bellafill injector/pdo threads provider (dr.(b)(6)) had dismissed the patient from her practice.Per the doctor seeing her subsequent to dr.(b)(6) in 2017, dr.(b)(6), there is nothing wrong with bellafill and the patient has psychiatric problems.The issue at that time was determined to be the pdo threads were placed too shallowly and the patient was informed.Two bellafill lots were reported by the patient in 2017 as being used in her bellafill procedure in (b)(6) 2016: f161013, udi - (b)(4), exp date: 06/07/2017, manufacturing date: 02/09/2016.F161058, udi - (b)(4), exp date: 09/30/2017, manufacturing date: 05/10/2016.Both lots were reviewed and no issues were noted.Suneva has left messages for the patient at the number provided and no additional information has been received at this time.Suneva will update this submission if any new information is received.Patient relays she was told by a current doctor that the threads are pushing the bellafill around her body.The name of the doctor who told her this is unknown at this time.Bellafill syringes are single use devices that are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".
 
Event Description
Patient states her teeth are falling out (9 so far) related to a nova threads procedure that occurred at the same time as bellafill dermal filler injection.In (b)(6) 2016.Patient also relays she was told by a different doctor that the threads are pushing the bellafill around her body.The name of the doctor who told her this is unknown at this time.The patient believes there is product coming out of her feet, toes, fingers, fingertips, and that it's in her mouth now.The patient states she has contacted nova threads but received no help and is now contacting suneva.
 
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Brand Name
BELLAFILL DERMAL FILLER
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego CA 92121
Manufacturer (Section G)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego CA 92121
Manufacturer Contact
stacy lewis
5870 pacific center blvd.
san diego, CA 92121
8587685492
MDR Report Key12029627
MDR Text Key265681606
Report Number3003707320-2021-00008
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/07/2017
Device Model NumberGBF0508
Device Catalogue NumberGBF0508
Device Lot NumberF161013
Was Device Available for Evaluation? No
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age66 YR
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