MIRADRY SYSTEM
Received Aug 9, 2025 · Event occurred Jul 10, 2025
Report 3008082710-2025-70021 · MDR key 22766308
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
19H1000-CA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR · Female
- High Blood Pressure/ Hypertension
- Contact Dermatitis
- High Blood Pressure/ Hypertension
- Contact Dermatitis
Narrative
Description of Event or Problem
PATIENT EXPERIENCED A SEVERE ALLERGIC AROUND THE EYE AND FURTHER PROGRESSED TO A RASH AROUND UNDERARMS/TREATMENT. PATIENT SELF MEDICATED WITH ANTIHISTAMINES PRESCRIBED FROM ALLERGIST AND IBUPROFEN. FOLLOW UP INFORMATION RECEIVED IN 07/31/2025 INDICATED SYMPTOMS WERE RESOLVING.
Additional Manufacturer Narrative
FOLLOW-UP #1 ADDED INFORMATION REGARDING PATIENT CONDITION AND CORRECT HEALTH EFFECT CLINICAL CODE.
Description of Event or Problem
PATIENT EXPERIENCED A SEVERE ALLERGIC REACTION POST MIRADRY TREATMENT.