MIRADRY SYSTEM
Received Dec 18, 2020 · Event occurred Apr 26, 2017
Report 3008082710-2020-00034 · MDR key 11042017
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
MN-MD4000-MC-GBCatalog number
MN-MD4000-MC-GB
Lot number
15H0069
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
44 YR
- Swelling
- Fibrosis
- Swelling
- Fibrosis
Narrative
Additional Manufacturer Narrative
IT WAS NOTED THAT THERE WAS VERY LITTLE TUMESCENT FLUID USED DURING TREATMENT, WHICH MAY, OR MAY NOT HAVE CONTRIBUTED TO THE EVENT. THE RATE SEEN (89 WORLDWIDE REPORTABLE INCIDENTS OUT OF ESTIMATED 224,000+ PROCEDURES PERFORMED TO DATE) IS APPROXIMATELY 0.039% OF THE PROCEDURES AND WITHIN THE ACCEPTABLE RANGE AS IDENTIFIED IN RISK ANALYSIS DOCUMENTATION.
Description of Event or Problem
PATIENT COMPLAINING ABOUT SWELLING ON TREATED AREA AND PROLONGED INTRA-LESION IN THE TREATED AREA. RADIOLOGY REPORT INDICATES THAT THE FEATURES ARE SUGGESTIVE OF REACTIVE SUBCUTANEOUS MILD FIBROSIS TO PREVIOUS INJECTION.