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

Model Number AF0508

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient diagnosed with mild xanthelasma under the eyes about 3-4 years after off-label bellafill dermal filler injection in the tear troughs.At this time, per the diagnosing physician, dr.Windle, it not very noticeable and no treatment is recommended.While xanthelasma is not harmful, it does require treatment to resolve.The patient was injected off-label in the tear troughs on 3 occasions by dr.(b)(6).On (b)(6) 2014, lot f141077, model af0508, expiration date: 02/29/2016; manufacture date: 09/19/2014; udi: n/a.On (b)(6) 2015, lot f151052, model gbf0508, expiration date: 10/02/2016; manufacture date: 05/09/15; udi: (b)(4).On (b)(6) 2015 (exact date not provided), lot f151097, model gbf0508, expiration date: 01/09/2017; manufacture date: 08/07/2015; udi: (b)(4).Per dr.(b)(6), the patient came in for a follow up and had vague yellowish areas under the eyes.The yellow areas appeared to be diminishing on their own, waxing and waning.She did not see a relation to the bellafill injections.Dr.(b)(6) is aware of bellafill indications for use.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.On (b)(6) 2019: (b)(6) was informed by dr.(b)(6) that the patient was diagnosed and confirmed with mild xanthelasma under the eyes.Per dr.(b)(6), potential causes include genetics and can also be sun-damage-related; xanthelasma is sometimes associated with high cholesterol, but not always.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.Bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit." all 3 reported lots (f141077, f151052, and f151097) had expired at the time of the report; therefore, retained lot samples could not be reviewed.Manufacturing records were reviewed for all 3 lots.All lots were manufactured according to approved work instructions and met all acceptance criteria upon release.

Event Description

Patient diagnosed with mild xanthelasma under the eyes about 3-4 years after off-label bellafill dermal filler injection in the tear troughs.At this time, per the diagnosing physician, is not very noticeable and no treatment is recommended at this time; however xanthelasma requires treatment to resolve.

• 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 ; 8587685492
• MDR Report Key: 8787275
• MDR Text Key: 150955837
• Report Number: 3003707320-2019-00007
• 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
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: AF0508
• Device Catalogue Number: AF0508
• Device Lot Number: F141077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• 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: 66 YR