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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 (SUSPECTED)
Device Problem Off-Label Use (1494)
Patient Problems Abscess (1690); Patient Problem/Medical Problem (2688)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Medical intervention required. Patient with a suspected abscess that presented ~3 months after off-label bellafill injection on the bridge of the nose requiring antibiotics. On (b)(6) 2019: the doctor reported a patient who presented with about 1/4 inch of swelling and acute redness about 3 months after off-label bellafill injection with less than 1 syringe on the bridge of the nose. The doctor called the injection on the bridge of the nose a "liquid rhinoplasty". On (b)(6) 2019: it was reported that the swelling and redness may be due to a suspected abscess, possibly a deeper abscess like cystic acne, that may or may not be related to the bellafill injection (which occurred 3 months prior to the onset of the swelling and acute redness). As a result, the patient has been placed on antibiotics. It was also reported that the patient had no problems for the first 3 months after injection. The date of injection and bellafill lot number have not been provided after 3 requests on (b)(6) 2019 and (b)(6) 2019; therefore bellafill use cannot be confirmed at this time. Per the doctor: the patient has had no other fillers or facial treatments in the affected area. The patient has no other medical conditions and is taking no other medications. 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. " bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
 
Event Description
Medical intervention required. Patient with a suspected abscess that presented ~3 months after off-label bellafill injection on the bridge of the nose requiring antibiotics.
 
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Brand NameBELLAFILL DERMAL FILLER
Type of DeviceIMPLANT, 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 Key9468690
MDR Text Key187536414
Report Number3003707320-2019-00022
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGBF0508 (SUSPECTED)
Device Catalogue NumberGBF0508 (SUSPECTED)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1
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