DeathOUB
MIRADRY SYSTEM
Received Jul 14, 2022
Report 3008082710-2022-70023 · MDR key 15015305
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCLot number
222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Necrosis
- Necrosis
Narrative
Description of Event or Problem
NECROTIZING FASCIITIS COMPLICATED WITH STREPTOCOCCAL TOXIC SHOCK SYNDROME RESULTING IN FATAL CONSEQUENCE POST MIRADRY AS NOTED IN PUBLICATION (LEGAL MEDICINE 58.) DEVICE WAS USED OFF LABEL.
Additional Manufacturer Narrative
ISSUE WAS DISCOVERED BY MIRADRY ON (B)(6) 2022 DURING A ROUTINE REVIEW OF SOCIAL MEDIA. ISSUE WAS PUBLISHED IN LEGAL MEDICINE 58. NO ADDITIONAL PATIENT, PRACTICE, DEVICE, OR TREATMENT INFORMATION WAS PROVIDED IN THE ARTICLE. DEVICE WAS USED OFF-LABEL.