MIRADRY SYSTEM
Received Sep 14, 2023
Report 3008082710-2023-70040 · MDR key 17750471
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Abscess
- Abscess
Narrative
Description of Event or Problem
MIRADRY PROCEDURE WAS DONE RIGHT AXILLA BEGAN TO SLOWLY SWELL, DEVELOPED PURPLE BRUISING, THEN PINPOINT HOLE OPENED AND STARTED DRAINING BLOODY FLUID. SOME FLUID WAS SEND OFF FOR CULTURE EARLY (B)(6) 2023. IT WAS NEGATIVE FOR INFECTION. IT'S (B)(6) AND THE ABSCESS IS BACK BUT IT'S WORSE. VERY PAINFUL, SWOLLEN, AND BRUISED. THERE'S ANOTHER PINPOINT HOLE THAT OPENED UP AND FLUID STARTED LEAKING DOWN HER SIDE. SHE TRIED SQUEEZING IT AND COPIOUS AMOUNTS OF GELATINOUS BROWN FLUID, BLOOD CLOTS, AND SMALL HARD PLUGS CAME OUT. THERE SEEMS TO BE NO END TO THE AMOUNT OF FLUID IN THERE. SHE HAS TO KEEP CHANGING THE GAUZE PAD UNDER HER ARM. SHE'S GOING TO HAVE TO HAVE A SURGICAL INCISION AND DRAINAGE OF THE ABSCESS.
Additional Manufacturer Narrative
NO FURTHER INFORMATION AVAILABLE. COMPLAINT WAS GIVEN VIA SOCIAL MEDIA AS WELL AS MEDWATCH REPORT (MW5144772). REACHED OUT TO PATIENT WITH NO RESPONSE.