MIRADRY SYSTEM
Received Jul 9, 2025 · Event occurred May 3, 2025
Report 3008082710-2025-70016 · MDR key 22464392
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
22 YR · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
ON MAY 11, DURING A MEDICAL EXAMINATION, REDNESS WAS OBSERVED BY THE PHYSICIAN EXTENDING FROM THE PATIENT'S LEFT ARMPIT TO THE UPPER ARM. BASED ON THE CLINICAL FINDINGS, THE CONDITION WAS ASSESSED AS AN INFLAMMATORY-STAGE INFECTION, AND THE PATIENT WAS PRESCRIBED CEFACLOR CAPSULES FOR 7 DAYS. ON MAY 13, THE PHYSICIAN PERFORMED AN INCISION AND DRAINAGE PROCEDURE ON THE PATIENT¿S LEFT ARMPIT. THE SPECIFIC MEDICATIONS USED DURING THE PROCEDURE ARE UNKNOWN.
Additional Manufacturer Narrative
REVIEW OF THE DEVICE DID NOT IDENTIFY ANY MALFUNCTIONS THAT CAUSED OR CONTRIBUTED TO THIS EVENT.