InjuryOUB
MIRADRY SYSTEM
Received Sep 24, 2021 · Event occurred May 22, 2021
Report 3008082710-2021-00007 · MDR key 12530164
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
30 YR
- Skin Infection
- Skin Infection
Narrative
Description of Event or Problem
ON (B)(6) 2021, 4 DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN INFECTION THAT REQUIRED ADDITIONAL MEDICAL INTERVENTION. THE PATIENT WAS PRESCRIBED 2 ANTIBIOTICS (BACTRIM & CEPHALEXIN). ON (B)(6) 2021 AND (B)(6) 2021, THE PATIENT WENT INTO URGENT CARE FOR ID & CULTURE AND WOUND CARE. THE CULTURE RETURNED AS PSEUDOMONAS.