MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number GBF0508

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

Patient ((b)(6)) was injected off-label with bellafill by dr.(b)(6) under the eyes on two occasions: (b)(6) 2015 in the tear troughs with lot f151077; (b)(6) 2016 in the lower lids with an unknown bellafill lot.Suneva conducted a review of lot f151077, which was injected during the patient's 1st bellafill procedure on (b)(6) 2015.No issues were found.The lot was manufactured in accordance with approved work instructions and met acceptance criteria at time of product release.Review of retained samples found the lot continues to meet release criteria.A shipping history of bellafill lots shipped to dr.(b)(6) was generated to determine potential lots that may have been used during the patient's 2nd bellafill procedure of (b)(6) 2016.A lot review has been initiated for these potential lots and results will be provided upon completion.The patient developed lumps/bumps, swelling, and discoloration after bellafill injection in the under eye area, which is an off-label location.The bellafill injector (dr.(b)(6)) is aware of bellafill indications for use.The patient's surgery was performed by: (b)(6).

Event Description

Surgical intervention required to resolve lumps/bumps, swelling, and discoloration after off-label bellafill injection under the eyes.Patient ((b)(6)) was injected off-label with bellafill by dr.(b)(6) under the eyes on two occasions: (b)(6) 2015 in the tear troughs with lot f151077; (b)(6) 2016 in the lower lids with an unknown bellafill lot.The patient had immediate swelling after both injections and reported on (b)(6) 2017 that she has lumps/bumps, swelling and discoloration in the eye area, and she is seeing another physician, dr.(b)(6), to evaluate her current issues.She also reported on (b)(6) 2017 that the swelling after the (b)6) 2016 injections has persisted.On (b)(6) 2017 the patient reported that dr.(b)(6) had removed the bellafill with surgery about 2 weeks prior.On (b)(6) 2017, after many attempts to contact dr.(b)(6) to determine rationale for surgery, his office reported that they had tried other options that did not work and indicated that surgical removal was the only recourse.The patient is now 6 weeks post-surgery and is showing significant improvement.They believe there is some residual product that is causing some swelling and they are treating with steroids at this time.

Manufacturer Narrative

07/18/17 update: a shipping history of bellafill lots shipped to dr.(b)(6) was generated to determine potential lots that may have been used during the patient's 2nd bellafill procedure of (b)(6) 2016.Lot reviews have been completed for the potential lots.No issues were found.The lots were manufactured in accordance with approved work instructions and met acceptance criteria at time of product release.Review of retained samples found the lots continue to meet release criteria.Previously provided info: patient (b)(6) was injected off-label with bellafill by dr.(b)(6) under the eyes on two occasions: (b)(6) 2015 in the tear troughs with lot f151077.(b)(6) 2016 in the lower lids with an unknown bellafill lot.Suneva conducted a review of lot f151077, which was injected during the patient's 1st bellafill procedure on (b)(6) 2015.No issues were found.The lot was manufactured in accordance with approved work instructions and met acceptance criteria at time of product release.Review of retained samples found the lot continues to meet release criteria.A shipping history of bellafill lots shipped to dr.(b)(6) was generated to determine potential lots that may have been used during the patient's 2nd bellafill procedure of (b)(6) 2016.A lot review has been initiated for these potential lots and results will be provided upon completion.The patient developed lumps/bumps, swelling, and discoloration after bellafill injection in the under eye area, which is an off-label location.The bellafill injector (dr.(b)(6) is aware of bellafill indications for use.The patient's surgery was performed by: dr.(b)(6).

Event Description

Surgical intervention required to resolve lumps/bumps, swelling, and discoloration after off-label bellafill injection under the eyes.Patient (b)(6) was injected off-label with bellafill by dr.(b)(6) under the eyes on two occasions: - (b)(6) 2015 in the tear troughs with lot f151077.- (b)(6) 2016 in the lower lids with an unknown bellafill lot.The patient had immediate swelling after both injections and reported on (b)(6) 2017 that she has lumps/bumps, swelling and discoloration in the eye area, and she is seeing another physician, dr.(b)(6), to evaluate her current issues.She also reported on (b)(6) 2017 that the swelling after the 09/2016 injections has persisted.On (b)(6) 2017 the patient reported that dr.(b)(6) had removed the bellafill with surgery about 2 weeks prior.On (b)(6) 2017, after many attempts to contact dr.(b)(6) to determine rationale for surgery, his office reported that they had tried other options that did not work and indicated that surgical removal was the only recourse.The patient is now 6 weeks post-surgery and is showing significant improvement.They believe there is some residual product that is causing some swelling and they are treating with steroids at this time.

• 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 ; 8585509999
• MDR Report Key: 6659079
• MDR Text Key: 78126608
• Report Number: 3003707320-2017-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/26/2016
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F151077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 05/22/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR