MIRADRY SYSTEM
Received Jul 28, 2021 · Event occurred Jul 6, 2021
Report 3008082710-2021-00004 · MDR key 12242763
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MC-MXCatalog number
MN-MD4000-MC-MX
Lot number
MN-MD4000-MC-MX
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
23 YR
- Cardiac Arrest
- Cardiac Arrest
Narrative
Additional Manufacturer Narrative
NO MALFUNCTION OR ALLEGATION OF DEFICIENCY WITH THE MIRADRY DEVICE WAS REPORTED. THE ADVERSE EVENT OCCURRED IMMEDIATELY FOLLOWING ADMINISTRATION OF LOCAL ANESTHESIA, AND THE MIRADRY DEVICE WAS NEVER USED DURING THIS CASE.
Description of Event or Problem
PATIENT WENT INTO CARDIAC ARREST IMMEDIATELY AFTER RECEIVING LOCAL ANESTHESIA INJECTION, PATIENT DIED BEFORE MIRADRY DEVICE WAS USED. AT NO TIME WAS CLINIC ABLE TO START TREATMENT, AS SOON AS THEY PLACED BOLUSES OF ANESTHESIA THE PATIENT BEGAN WITH SHOCK AND THE RESPIRATORY ARREST OCCURRED IN MINUTES.