InjuryOUB
MIRADRY SYSTEM
Received Dec 26, 2023 · Event occurred Sep 30, 2023
Report 3008082710-2023-70047 · MDR key 18395604
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
44 YR · Male
- Numbness
- Numbness
Narrative
Description of Event or Problem
NURSE INJECTED THE PATIENT WITH TOO MUCH LIDOCAINE. RN ACCIDENTALLY USE LIDOCAINE 1% AND NOT LIDOCAINE EITH EPI. PATIENT HAD AN OVERDOSE AND HAD TO VISIT THE HOSPITAL. HE IS REPORTING NUMBNESS IN ONE BICEP, WHICH HE STATES HAS ALREADY STARTED TO IMPROVE.
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE DATA INDICATED NO ISSUE WITH THE SYSTEM THAT WOULD HAVE CAUSED THE ADVERSE EVENT.