InjuryOUB
MIRADRY SYSTEM
Received Jan 22, 2024
Report 3008082710-2024-70005 · MDR key 18553572
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
50 YR · Female
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA INDICATED THAT THERE IS NO ISSUE WITH THE DEVICE THAT WOULD CAUSE THE ADVERSE EVENT.
Description of Event or Problem
3RD DEGREE BURN. POST TX CLEANSED WITH ALCOHOL AND APPLIED BACITRACIN ON TOP OF AREA TREATED. PT WAS TO CLEANSE TREATED AREA W HIBICLENSE AND THEN APPLIED BACITRACIN 2X THAT DAY, THEN 3XS NEXT DAY. PT WAS GIVEN 500MG IBOPROFEN, AND TOLD TO TAKE EVERY 4 HRS FOR DAY ONE.