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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 Off-Label Use (1494); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2018: patient indicated via facebook comment that she had lumps that required surgical removal.Suneva medical requested contact information from patient (i.E.Phone and/or email address).No response to suneva attempts until (b)(6) 2018.On (b)(6) 2018: patient responded with her email address.On (b)(6) 2018: suneva requested additional information.On (b)(6) 2018: patient responded and reported that the lumps began about 3 years after her first artefill dermal filler injection requiring excision about a year ago after several years of kenalog and/or 5fu injections.Other more recent lumps are believed by the injector to be biofilm infection requiring antibiotics.Patient was placed on zpack.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in (b)(6) 2012, and (b)(6) 2012, 2013, and 2014.At the reported time of the injections, the artefill dermal filler indications was for correction of the nasolabial folds.Suneva will begin attempting to contact the injector and also current doctor (dr.(b)(6)) next week in order to obtain artefill lot numbers and other injection and treatment information.Artefill dermal filler use is to be determined.Artefill dermal filler is a single use device.Syringes are typically discarded after injection.
 
Event Description
Patient reported lumps that began about 3 years after her first artefill dermal filler injection requiring excision and also biofilm requiring antibiotics.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in (b)(6) 2012, and (b)(6) 2012, 2013, and 2014.
 
Event Description
Patient reported lumps that began about 3 years after her first artefill dermal filler injection requiring excision and also biofilm requiring antibiotics.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in late 2014 or in 2015 (injection date/month unknown).
 
Manufacturer Narrative
06/28/2018: patient indicated via facebook comment that she had lumps that required surgical removal.Suneva medical requested contact information from patient (i.E.Phone and/or email address).No response to suneva attempts until 07/22/2018.07/22/2018: patient responded with her email address.07/24/2018: suneva requested additional information.07/25/2018: patient responded and reported that the lumps began about 3 years after her first artefill dermal filler injection requiring excision about a year ago after several years of kenalog and/or 5fu injections.Other more recent lumps are believed by the injector to be biofilm infection requiring antibiotics.Patient was placed on zpack.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in (b)(6) 2012, and (b)(6) 2012, 2013, and 2014.At the reported time of the injections, the artefill dermal filler indications was for correction of the nasolabial folds.Suneva will begin attempting to contact the injector and also current doctor (dr.Edward zimmerman, las vegas, nv) next week in order to obtain artefill lot numbers and other injection and treatment information.Artefill dermal filler use is to be determined.Artefill dermal filler is a single use device.Syringes are typically discarded after injection.09/13/2018 - follow up #1: as of 08/13/2018, suneva received information from the (b)(4)injecting office (dr.(b)(6) office) which required correction of the original mdr submission.The following sections were corrected.B5: corrected the injection time frame per information provided by the injecting office: injections occured in late 2014 or in 2015.Exact timeframe is unknown.D1: changed product name from artefill dermal filler to (b)(4) dermal filler based on lot number provided by the injecting office.D4: updated the model number to gbf0508 based on lot number provided by the injecting office.D4: the lot number is now known: f141109 (based on info provided by the injecting office).D4 the lot number expiration date is: 04/21/12016.D4: the udi number is (b)(4).D5: the operator of the device is a "health professional".D6: updated the implant date per information provided by the injecting office.G7: this is follow up #1.09/13/2018 - follow up #2: info we forgot to add in prior follow up (#1) today.H2: follow-up is additional info and corrected data.H4: device manufacture date is 12-01-2014.H6: device code: removed 3190.H6: method code: added 3331, removed 4119.H6: results code: added 213; removed 3233.H6: conclusions code: removed 11.G7: this is follow up #2.
 
Manufacturer Narrative
06/28/2018: patient indicated via facebook comment that she had lumps that required surgical removal.Suneva medical requested contact information from patient (i.E.Phone and/or email address).No response to suneva attempts until 07/22/2018.07/22/2018: patient responded with her email address.07/24/2018: suneva requested additional information.07/25/2018: patient responded and reported that the lumps began about 3 years after her first artefill dermal filler injection requiring excision about a year ago after several years of kenalog and/or 5fu injections.Other more recent lumps are believed by the injector to be biofilm infection requiring antibiotics.Patient was placed on zpack.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in (b)(6) 2012, and (b)(6) 2012, 2013, and 2014.At the reported time of the injections, the artefill dermal filler indications was for correction of the nasolabial folds.Suneva will begin attempting to contact the injector and also current doctor (dr.(b)(6)) next week in order to obtain artefill lot numbers and other injection and treatment information.Artefill dermal filler use is to be determined.Artefill dermal filler is a single use device.Syringes are typically discarded after injection.09/13/2018 - follow up #1: as of 08/13/2018, suneva received information from the (b)(4) injecting office (dr.E.Zimmerman's office) which required correction of the original mdr submission.The following sections were corrected.B5: corrected the injection timeframe per information provided by the injecting office: injections occured in late 2014 or in 2015.Exact timeframe is unknown.D1: changed product name from artefill dermal filler to (b)(4) dermal filler based on lot number provided by the injecting office.D4: updated the model number to gbf0508 based on lot number provided by the injecting office.D4: the lot number is now known: f141109 (based on info provided by the injecting office).D4 the lot number expiration date is: 04/21/12016.D4: the udi number is (b)(4).D5: the operator of the device is a "health professional".D6: updated the implant date per information provided by the injecting office.G7: this is follow up #1.
 
Event Description
Patient reported lumps that began about 3 years after her first artefill dermal filler injection requiring excision and also biofilm requiring antibiotics.Patient was injected off-label under the eyes, around the side of the mouth, above eyebrows and in between eyes in late 2014 or in 2015 (injection date/month unknown).
 
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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
MDR Report Key7732237
MDR Text Key115419313
Report Number3003707320-2018-00014
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,Followup,Followup
Report Date 07/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/21/2016
Device Model NumberGBF0508
Device Catalogue NumberGBF0508
Device Lot NumberF141109
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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