FDA Adverse Event Injury Summary report: N

MIRADRY SYSTEM

MDR report key: 22352226 · Received June 27, 2025

Report

Report Number
3008082710-2025-70013
Event Type
Injury
Date Received
June 27, 2025
Date of Event
May 30, 2025
Report Date
May 30, 2025
Manufacturer
MIRADRY INC.
Product Code
OUB
PMA / PMN Number
K1311162
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 0

(B)(6) - PATIENT VISITED PHYSICIAN COMPLAINING OF REDNESS AND PAIN IN RIGHT AXILLA. ALSO STATING THEY SAW THEIR PRIMARY CARE PROVIDER AS WAS PRESCRIBED CEPHALEXIN BID, AND AFTERWARDS AS SWITCHED TO BACTRIM DC. C/O "BUMPS" ON BOTH AXILLA, WITH REDNESS AND PAIN ONLY TO RIGHT. PHYSICIAN ALSO ADMINISTERED 1/2 CC INJECTION OF KENALOG 40 MIXED WITH 1/2 CC 1/4% MARCAINE TO RIGHT AXILLARY NODULES. (B)(6) - VISITED PHYSICIAN TO REPORT RIGHT AXILLA RESPONDED WELL BUT FURTHER DEVELOPED SWELLING, PAIN, AND REDNESS. ON EXAM, LEFT AXILLA RESOLVED, BUT RIGHT AXILLA CONTAINED LARGE "EGG" SIZED FLUCTUANT. THIS WAS DRAINED WITH 18G NEEDLE AND DRESSED, SAMPLES WERE TAKEN FOR TESTING WITH PATIENT RX AUGMENTIN 500MG QD. (B)(6) - PATIENT VISITED HOSPITAL TO HAVE RIGHT AXILLA DRAINED. DRAIN WAS ALSO PLACED AND PATIENT SWITCHED PRESCRIPTION TO BACTRIM. TESTS CAME BACK AS STAPHYLOCOCCUS AUREUS. (B)(6) - PATIENT IS BETTER WITH SWELLING AND INFECTION RESOLVING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
939074 MIRADRY SYSTEM MICROWAVE DERMATOLOGIC SYSTEM OUB MIRADRY INC. MN-MD4000-MC

Patients

Seq Age Sex Outcome Treatment
1 15 YR Male