MIRADRY SYSTEM
Received Dec 30, 2020 · Event occurred Oct 15, 2020
Report 3008082710-2020-00036 · MDR key 11098863
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
MN-MD4000-MC-KRCatalog number
MN-MD4000-MC-KR
Lot number
18H0146
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR
- Inflammation
- Swelling
- Fluid Discharge
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Inflammation
- Swelling
- Fluid Discharge
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE RATE SEEN (100 WORLDWIDE REPORTABLE INCIDENTS OUT OF ESTIMATED 224,000+ PROCEDURES PERFORMED TO DATE) IS APPROXIMATELY 0.04% OF THE PROCEDURES AND WITHIN THE ACCEPTABLE RANGE AS IDENTIFIED IN RISK ANALYSIS DOCUMENTATION.
Description of Event or Problem
TWO DAYS POST MIRADRY TREATMENT PATIENT PRESENTED WITH A SMALL BLISTER, ANTIBIOTICS AND TOPICALS WERE PRESCRIBED TO TREAT THE WOUNT. ABOUT ONE WEEK LATER AN INCREASE IN THE WOUND SIZE WAS NOTICED, AS OF DECEMBER, THE WOUND IS STILL OOZING UNDER THE SKIN AND IS HARD. THERE IS NO SIGN OF INFECTION, HOWEVER THERE IS INFLAMMATION. WOUND APPEARS ISCHEMIC, NOT FRESH AND CLEAN.