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

Model Number GBF0508 (SUSPECTED)

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

Patient Problems Post Operative Wound Infection (2446); Patient Problem/Medical Problem (2688)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The account reported on 2019-06-25 that the patient was injected with bellafill dermal filler about 5-6 years ago (date unknown) in multiple off-label locations (nose, forehead, eyebrows, chin, jawline) and developed an infection in the nose at the time of injection, which required treatment to resolve.They prescribed antibiotics and the infection resolved at that time.There were no other infections reported in the other areas injected at the same time as the nose.Notes: it was also reported on 2019-06-25 that the patient has some current redness and warmth in the nose area, but was not noted by the doctor to be a concern.The patient is also reported to have suspected granuloma which began presenting about a year ago in all areas of injection (nose, forehead, eyebrows, chin, jawline).There is no indication at this time that medical intervention is required to resolve the suspected granuloma.Granuloma is an anticipated patient event that is documented in the bellafill instructions for use.Clinical studies support that granuloma may resolve over time with or without treatment.The lot numbers are unknown at this time.The injection files had been archived by the account.The date of injection is unknown at this time; therefore potential lot numbers cannot be determined and bellafill dermal filler use is not confirmed.The infection in the nose resolved after treatment with antibiotics, after the dermal filler injections ~5-6 years ago, and no further information is available regarding the infection.The suspected root cause is off-label use.Per the bellafill instructions 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.The instructions for use also contains the precaution: as with all transcutaneous procedures, bellafill injection carries a risk of infection.The usual precautions associated with injectable materials should be followed.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

Account reported that the patient was injected with bellafill dermal filler about 5-6 years ago (date unknown) in multiple off-label locations (nose, forehead, eyebrows, chin, jawline) and developed an infection in the nose at that time, which required 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: 8829047
• MDR Text Key: 152465949
• Report Number: 3003707320-2019-00008
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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