Description of Event or Problem · 0
ON DECEMBER 30, 2025, CARTESSA AESTHETICS BECAME AWARE OF A REPORTED ADVERSE EVENT SUBMITTED BY A PATIENT, CONVERNING THE SHENB VIRTUE RF MICRONEEDLING DEVICE VIA FDA MEDWATCH REPORT #MW5180017. THE ADVERSE EVENT REPORTED WAS: "VIRTUE RF MICRONEEDLING LEFT ME WITH DEPRESSION SCARS/TRAM TRACK SCARRING." NO INFORMATION ABOUT THE DATE THE REPORTED EVENT OCCURRED, THE SITE WHERE THE REPORTED EVENT TOOK PLACE NOR ANY INFORMATION ABOUT THE NAME OF THE ACTUAL PHYSICIAN WHO PERFORMED THE TREATMENT NOR ANY ID INFORMATION ABOUT THE DEVICE HAS BEEN DISCLOSED IN THE REPORT. A REVIEW OF INTERNAL COMPLAINT LOGS, ADVERSE EVENT LOGS, SERVICE REQUESTS AND EMAILS DID NOT PRODUCE ANY INFORMATION ABOUT THE ACTUAL DEVICE INVOLVED IN THE EVENT NOR ANY INFORMATION ABOUT THE SITE OR ACTUAL PHYSICIAN INVOLVED IN THE EVENT. AS SUCH, WE ARE UNABLE TO INSPECT THE DEVICE NOR CONTACT THE PHYSICIAN THAT PERFORMED THE TREATMENT TO GATHER DETAILS AND FORMALLY INVESTIGATE. WE, THE INITIAL IMPORTER AND DISTRIBUTOR OF THE DEVICE IN THE UNITED STATES, BECAME AWARE OF THE REPORTED EVENT ON DECEMBER 30, 2025, BY EMAIL VIA FDA MEDWATCH REPORT MW5180017. ON DECEMBER 30, 2025, CARTESSA AESTHETICS NOTIFIED THE DEVICE MANUFACTURER, SHENB CO. LTD. OF THE RECEIPT OF MW5180017. PER 21 CFR PART 803, AND WITH THE SUPPORT OF THE MANUFACTURER, WE HAVE EVALUATED THIS EVENT AS NOT REPORTABLE DUE TO THE FACT THAT SCARRING AND TRACK MARKS ARE COMMON AND EXPECTED AFTER TREATMENT WITH THIS DEVICE. FOLLOWING PROPER POST-TREATMENT CARE, THESE HEAL IN 1-2 WEEKS. WE DON'T FIND THAT THIS CASE MEETS THE CRITERIA FOR REPORTING AN ADVERSE EVENT. WE WILL CONTINUE TO INVESTIGATE THE ORIGIN OF THIS REPORTED EVENT AND WILL UPDATE THIS RESPONSE IF WE ARE ABLE TO GATHER ADDITIONAL DETAILS.