MIRADRY SYSTEM
Received Jan 14, 2025 · Event occurred Sep 26, 2024
Report 3008082710-2024-70019 · MDR key 21154367
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR · Female
- Swelling/ Edema
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
A DATA REVIEW WAS CONDUCTED AGAINST THE DEVICE AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THIS MDR IS BEING SUBMITTED LATE, AS THE INITIAL SUBMISSION ON NOVEMBER 12, 2024 FAILED. THIS WAS DETERMINED TO BE AN ISSUE WITH FDA¿S SYSTEM ACCEPTING MIRADRY¿S RENEWED SSL/SIGNING AND ENCRYPTION CERTIFICATE, WHICH HAD A LEADING ZERO IN THE SERIAL NUMBER. THIS WAS DETERMINED TO BE THE CAUSE OF THE MDR SUBMISSION FAILURE. FOLLOWING TROUBLESHOOTING WITH THE ESG HELP DESK, A NEW CERTIFICATE WAS OBTAINED AND UPLOADED, AND THE SUBSEQUENT MDR SUBMISSION ON DECEMBER 19, 2024 WAS SUCCESSFUL.
Description of Event or Problem
RECEIVED EMAIL FROM REP STATING THE PATIENT IS EXPERIENCING 10/10 NERVE & DISCOMFORT BILATERAL THAT IS ONGOING POST 2ND TX.. PATIENT WAS RX GABAPENTIN AND MEDROL DOSE PACK AND ADVISED TO MASSAGE AND STRETCH.