InjuryOUB
MIRADRY SYSTEM
Received Mar 14, 2022 · Event occurred Feb 14, 2022
Report 3008082710-2022-70005 · MDR key 13759668
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
- Numbness
- Numbness
Narrative
Description of Event or Problem
PATIENT REACHED OUT TO MIRADRY TO REPORT THAT THEIR LEFT ARM HURTS AND STILL NUMB SIX MONTHS POST TREATMENT. ADDITIONAL ATTEMPTS WERE MADE TO REACH OUT TO THE CUSTOMER WITH NO RESPONSE.
Additional Manufacturer Narrative
THREE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE WAS GIVEN.