MIRADRY SYSTEM
Received Jan 21, 2022 · Event occurred Oct 29, 2021
Report 3008082710-2022-70001 · MDR key 13314647
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC-CA
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
28 YR · Male
- Fluid Discharge
- Fluid Discharge
Narrative
Description of Event or Problem
PATIENT HAD HIS SECOND MIRADRY TREATMENT IN (B)(6) 2021. HE HAD HIS PREVIOUS FIRST TREATMENT (B)(6) 2021 WITH US WITHOUT ANY COMPLICATION. PATIENT STATED HE HAS A BILATERAL DISCHARGE FROM BOTH ARMPITS. THEY ARE SMALL AREAS WHICH DISCHARGE RED LIQUID. SWABS ARE (B)(6). PATIENT WAS GIVEN 2 COURSES OF ANTIBIOTICS FROM PHYSICIAN AND CLINDAMYCIN GEL AND DOXYCYCLINE ORAL. THE PHYSICIAN OPENED UP THE LYMPHOCELE ON BOTH ARMPITS. THE LEFT WAS SUCCESSFUL, AND THE PHYSICIAN PACKED IT AND KEPT CHANGING THE DRESSING EVERY 2 DAYS, THE PHYSICIAN DID NOT PUT A DRESSING IN THE LEFT ARMPIT FOR A WEEK AND THE PATIENT SAYS THERE IS A LITTLE LEAK. ON THE RIGHT SIDE IT IS A 0.5 CM DEEP HOLE WITH IT EXTENDING LATERALLY 2 CM. THE PHYSICIAN PACKED IT BUT THE CUSTOMER SAYS IT HURTS ONCE IT IS IN THERE. THE PHYSICIAN IS PACKING WITH CURITY ANTIMICROBIAL PACKING STRIPS.
Remedial action
- Patient Monitoring