MIRADRY SYSTEM
Received Dec 13, 2020 · Event occurred Nov 13, 2020
Report 3008082710-2020-00031 · MDR key 10999349
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
15H0540
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
40 YR
- Cyst(s)
- Pain
- Cyst(s)
- Pain
Narrative
Additional Manufacturer Narrative
THE RATE SEEN (39 WORLDWIDE REPORTABLE INCIDENTS OUT OF ESTIMATED 224,000+ PROCEDURES PERFORMED TO DATE) IS APPROXIMATELY (B)(4) OF THE PROCEDURES, AND WITHIN THE ACCEPTABLE RANGE AS IDENTIFIED IN RISK ANALYSIS DOCUMENTATION.
Description of Event or Problem
PATIENT CONTACTED HCP ON (B)(6) 2020, APPROX 15 DAYS POST MIRADRY TREATMENT, AND REPORTED A HOT, PAINFUL LUMP, (B)(6) WAS INFORMED AND PRESCRIBED DOXYCYCLINE BID FOR 10 DAYS. ON (B)(6) 2020, CULTURE TAKEN AND PATIENT DIAGNOSED WITH PSEUDOMONAS, ANTIBIOTICS SWITCHED FROM DOXYCYCLINE TO LEVAQUIN FOR 7X DAYS. PHYSICIAN DIAGNOSED PATIENT WITH AN EPIDERMAN INCLUSION CYST, IT WAS REPORTED BY THE HCP TO THE MANUFACTURER THAT THE CYST WAS RESOLVING.