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

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.

Manufacturer Narrative

Follow up #1: additional information was added to the following sections: b5: added: the doctor reports on 03/06/2020 that the product was explanted in (b)(6) 2020 with resulting orbital hemorrhage (which occurred on (b)(6) 2020).No loss of vision.The patient remains on antibiotics, currently clarithromycin and cipro.D7: added explant date of (b)(6) 2020.The surgery to remove the bellafill occurred ~2 weeks prior to the doctor's update to suneva on 03/06/2020.The exact date is unknown.G7: added follow-up #1.H2: this follow up is to provide additional information.H6: added patient code 1888 (hemorrhage).Narrative from original mdr submission of 10/25/2019: 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: on (b)(6)2014, artefill dermal filler, model: af0508, lot f141088, manufacture date: 10/17/2014, expiration date: 03/31/2016, udi: n/a.On (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 2mm 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.The doctor reports on 03/06/2020 that the product was explanted in (b)(6) 2020 with resulting orbital hemorrhage (which occurred on 03/05/2020).No loss of vision.The patient remains on antibiotics, currently clarithromycin and cipro.

• Brand Name: BELLAFILL DERMAL FILLER (PREVIOUSLY KNOWN AS ARTEFILL DERMAL FILLER)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca CA 92121
• MDR Report Key: 9240500
• MDR Text Key: 166341095
• Report Number: 3003707320-2019-00020
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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 Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: AF0508
• Device Catalogue Number: AF0508
• Device Lot Number: F141088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention