MIRADRY SYSTEM
Received Dec 2, 2021 · Event occurred Dec 20, 2020
Report 3008082710-2021-00018 · MDR key 12917592
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC-EU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
PATIENT WAS DIAGNOSED WITH HIDRADENITIS SUPPERATIVA. PATIENT REPORTED PAIN ON LEFT UNDER ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT WAS PHYSICALLY EVALUATED, DRIPPING OF WHITE LIQUID FROM ABSCESS, AND BLOOD TEST WERE TAKEN.
Additional Manufacturer Narrative
THE RESULTS OF THE BLOOD TEST WERE NORMAL. THE PATIENT WAS GIVEN ANTIBIOTICS ON (B)(6) 2020. IN (B)(6) 2020, THE PATIENT WAS NOT FEELING BETTER AND WAS ADVISED TO GO TO THE ER. THE PATIENT WAS TREATED FOR HIS ABSCESS AND GIVEN TWO DIFFERENT MEDICATIONS. ON (B)(6) 2021, PATIENT REPORTED ANOTHER ABSCESS ON HIS RIGHT UNDERARM. THE RIGHT UNDERARM BECAME WORSE AND THE PATIENT WENT BACK TO THE HOSPITAL; THE ON-SITE DOCTOR STATED THAT HIS UNDERARMS WERE BURNED.