MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL SKIN TEST (PREVIOUSLY KNOWN AS ARTEFILL SKIN TEST); IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number GBS0501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Medical intervention required.Patient with potential atypical response to the bellafill skin test (shortness of breath when going upstairs and a "flair" of a heart murmur).Patient treated with prednisone, allegra, and pepcid ac.Patient was injected with 0.1cc of the bellafill skin test in the forearm about 1 month prior to the report date of (b)(6) 2019.The exact date of injection is unknown.The bellafill skin test lot number has been requested.Reviews of manufacturing records and retained lot samples are pending once the lot number used is received.Suneva will relay the results in a follow-up to this submission.This is the 1st complaint report of "shortness of breath going upstairs" or "heart murmur" for the bellafill skin test.Per the injector, there was no anaphylactic response.Details: two (2) days after injection, the patient reported a rash on the forearm that spread around the arm.This is a typical positive response.The patient also later reported that the rash was also on the other arm.Also considered a known positive or equivocal response to the skin test.A few days after that, the patient reported shortness of breath when going up stairs.This is not a known positive response.Along with the shortness of breath when going up stairs, the patient's general practitioner relayed that the patient "has a flair of a heart murmur" that seems to be associated whenever she has an allergic response." this is also not a known positive response.The patient was put on prednisone, allegra and pepcid ac at that time.As of the evening of 10/24/19, the patient was reported as feeling fine and "doing well on prednisone".The injector is not sure that the reported atypical responses are associated wit the bellafill skin test, but is treating as such.Indications: "the bellafill skin test is intended to be administered intradermally into the volar forearm to identify individuals who might show hypersensitivity to injectable bovine dermal collagen devices.Patients so identified are ineligible for treatment with bellafill." bellafill skin test syringes are single use devices that are typically discarded after use.Per the bellafill skin test ifu: "discard the syringe after administration of the bellafill skin test." "bellafill skin test syringes are appropriate only for testing prior to treatment with bellafill.".

Event Description

Medical intervention required.Patient with potential atypical response to the bellafill skin test (shortness of breath when going upstairs and a "flair" of a heart murmur).Patient treated with prednisone, allegra, and pepcid ac.

• Brand Name: BELLAFILL SKIN TEST (PREVIOUSLY KNOWN AS ARTEFILL SKIN TEST)
• 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: 9365997
• MDR Text Key: 167760108
• Report Number: 3003707320-2019-00021
• 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: 11/22/2019

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: Health Professional
• Device Model Number: GBS0501
• Device Catalogue Number: GBS0501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/22/2019
• 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