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U.S. Department of Health and Human Services

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

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SUNEVA MEDICAL, INC. BELLAFILL SKIN TEST (PREVIOUSLY KNOWN AS ARTEFILL SKIN TEST) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
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Brand NameBELLAFILL SKIN TEST (PREVIOUSLY KNOWN AS ARTEFILL SKIN TEST)
Type of DeviceIMPLANT, 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 Key9365997
MDR Text Key167760108
Report Number3003707320-2019-00021
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020012
Number of Events Reported1
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
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGBS0501
Device Catalogue NumberGBS0501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
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 Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
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