MIRADRY
Received Aug 18, 2023 · Event occurred May 15, 2023
Report MW5144772 · MDR key 17585060
Device
Generic name
Instrument For Treatment Of Hyperhidrosis
Manufacturer
Miradry, Inc.Patient
20 YR · Female
- Abscess
- Bruise/Contusion
- Pain
- Fluid Discharge
- Thrombosis/Thrombus
- Swelling/ Edema
- Abscess
- Bruise/Contusion
- Pain
- Fluid Discharge
- Thrombosis/Thrombus
- Swelling/ Edema
Narrative
Description of Event or Problem
MIRADRY PROCEDURE WAS DONE IN (B)(6) AT (B)(6) LOCATED: (B)(6), PHONE NUMBER: (B)(6). 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 AUGUST 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.