MIRADRY SYSTEM
Received Jan 15, 2025 · Event occurred Nov 8, 2024
Report 3008082710-2024-70022 · MDR key 21158404
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
25 YR · Female
- Swelling/ Edema
- Swelling/ Edema
Narrative
Description of Event or Problem
PATIENT HAD FIRST MD TX IN (B)(6) 2023 AND CALLED THE CLINIC LAST WEEK STATING SHE HAD SOME BUMPS UNDER BOTH AXILLA SINCE 1 MONTH. PATIENT STATES BOTH BUMPS ARE THE SAME SIZE (SMALL EGG) AND IT FEELS SENSITIVE UPON TOUCH AND MOVEMENT. PATIENT HAS NO OTHER SYMPTOMS. PT HAD FOLLOW UP WITH DOCTOR WHO PERFORMED ELLIPTICAL BIOPSY-FIBROSCAR REARRANGEMENT AND TREATED THE PT WITH KENALOG INJECTION ON (B)(6).
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 (B)(6) 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 (B)(6) 2024 WAS SUCCESSFUL.