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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER) IMPLANT, DERMAL, FOR AESTHETIC USE

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SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Model Number AF0508
Device Problem Off-Label Use (1494)
Patient Problems Cellulitis (1768); Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
Medical intervention required. Patient with recurring preseptal cellulitis in the left medial eyelid area after off-label injection of bellafill in the tear troughs. Patient was injected with bellafill (previously known as artefill) on two (2) occasions in the tear troughs: (b)(6) 2014, artefill dermal filler, model: af0508, lot f141088, manufacture date: 10/17/2014, expiration date: 03/31/2016, udi: n/a. (b)(6) 2017, bellafill dermal filler, model gbf0508, lot f161157, manufacture date: 12/21/2016, expiration date: 05/10/2018, udi: (b)(4). The cellulitis first presented in (b)(6) 2017. Patient has been treated with biaxin x 3 weeks, 5fu, steroid weekly 9:1 x3. She's also undergone multiple im steroid injections from her artefill/bellafill injector, as well as been treated with colchicine. Dr. (b)(6) indicates he can palpate small 1 to 2 mm beads in the area. At last contact, dr. (b)(6) was planning to send samples to a lab for histology. The reporting doctor (dr. (b)(6)) who is treating the patient's cellulitis was not the artefill/bellafill injector. The patient was referred to dr. (b)(6) by the patient's artefill/bellafill injector, dr. (b)(6). 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 recurring preseptal cellulitis in the left medial eyelid area after off-label injection of bellafill in the tear troughs.
 
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Brand NameBELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER)
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego, ca CA 92121
Manufacturer (Section G)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego, ca CA 92121
Manufacturer Contact
pam misajon
5870 pacific center blvd.
san diego, ca, CA 92121
8587685492
MDR Report Key9240500
MDR Text Key166341095
Report Number3003707320-2019-00020
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,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2016
Device Model NumberAF0508
Device Catalogue NumberAF0508
Device Lot NumberF141088
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 Received09/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2014
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: 10/25/2019 Patient Sequence Number: 1
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