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

Model Number GBF0508

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Medical intervention (surgery) required to address lump after off-label bellafill dermal filler injection in the tear troughs.Timeline: on (b)(6) 2015: the patient (a nurse practioner) was injected with bellafill dermal filler off-label in the tear troughs by another nurse practitioner in her practice.On (b)(6) 2015: onset date of a lump in the right tear trough and discoloration under both eyes (~2 weeks after injection).On (b)(6) 2015: patient reported lump and discoloration to suneva medical (~1 month after injection).On (b)(6) 2015: patient reported that the discoloration appeared to be bruising.On (b)(6) 2015: file closed due to lack of response.On (b)(6) 2015: patient reports that the lump is still there but it was improving, settling down.File remained closed, pending additional information.On (b)(6) 2018: patient relayed to suneva on 03/09/2020 that she had the 1st surgery to address the lump "a couple of years ago." exact date was not provided.On (b)(6) 2020: suneva marketing forwarded an (b)(6) post by the patient, which indicated she just had her 2nd surgery to correct "bellafill that was injected in my tear trough 5 years ago." on (b)(6) 2020: suneva left a message for the patient regarding her (b)(6) post.On (b)(6) 2020: suneva spoke with the patient.She appreciated the follow up to her (b)(6) post and relays that she just had her 2nd surgery.The 1st surgery was a couple of years ago to remove the lump under the right eye.She states that she had previously tried 5fu and kenalog without success.It flared up "each time she pokes it." the recent 2nd surgery was a partial lower bleph under both eyes to remove the extra skin that occurred after prior instances of flaring/prolonged swelling.It was done for the right side more so than the left.The left was done for symmetry, she's doing fine after the 2nd surgery, but had significant swelling as is typical for her with treatment in this area and is taking prednisone to address.She will text her surgeon to see if he would like to discuss the case with us.She also states that her mother was injected in the cheeks on the same day with no subsequent issues.She understands that periocular injections are off-label for bellafill and appreciates that suneva has included a warning in the bellafill ifu related to injections in this area.She appreciates the opportunity to discuss and help improve patient safety.On (b)(6) 2020: the patient indicates that her "surgery has healed well.There is still a slight bump/nodule under the right eye.Probably not noticeable to most people, but it is to me." she believes her surgeon forgot to follow up with suneva.She will text her surgeon again to follow up with suneva.Lot review: review of manufacturing records found that lot f151043 was manufactured according to approved work instructions and met all acceptance criteria upon release.The lot has since expired, therefore, retained lot samples are not available for review.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, which is documented in the bellafill ifu.The following additional warning was added to the bellafill ifu in 2019: bellafill is not indicated for use in the periocular area (e.G.Tear trough), as the effects of injection in this location have not been studied.The following adverse events including, but not limited to, lumps, swelling, granulomas and vision loss due to vascular occlusion, have been reported in the post-market surveillance data with off-label injection in the periocular area.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.".

Event Description

Medical intervention (surgery) required to address lump after off-label bellafill dermal filler injection in the tear troughs.

• 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
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca
• Manufacturer Contact: pam misajon ; 5870 pacific center blvd.; san diego, ca ; 7685492
• MDR Report Key: 9925537
• MDR Text Key: 187864510
• Report Number: 3003707320-2020-00006
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2016
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F151043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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