InjuryOUB
MIRADRY SYSTEM
Received May 6, 2023
Report 3008082710-2023-70019 · MDR key 16883020
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
Female
- Skin Infection
- Skin Infection
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA WAS PERFORMED AND FOUND NO ISSUES WITH THE DEVICE THAT CAUSE THE ADVERSE EVENT.
Description of Event or Problem
THE PATIENT REPORTED THAT INITIALLY THEY HAD AN INFECTION IN (B)(6) 2023 THAT RESOLVED WITH ANTIBIOTICS; NOW HAS PEA SIZE BUMP THAT HAS BEEN REPORTED BY PATIENT TO CLINIC WITH NO PHYSICAL EXAM.