InjuryOUB
MIRADRY SYSTEM
Received Apr 18, 2023 · Event occurred Mar 18, 2023
Report 3008082710-2023-70014 · MDR key 16765762
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
Unknown
- Itching Sensation
- Itching Sensation
Narrative
Additional Manufacturer Narrative
A DATA REVIEW WAS CONDUCTED AND NOTHING WAS FOUND THAT WOULD HAVE CAUSED THIS ADVERSE EVENT.
Description of Event or Problem
THE TREATING PHYSICIAN REPORTED THAT THEIR PATIENT DEVELOPED UNCONTROLLABLE ITCHING IN HER ENTIRE BODY. DR. ORTIZ SUGGESTED BENADRYL. PATIENT WAS TAKEN TO THE ER WHERE THERE WERE GIVEN MEDICATION AND MORPHINE TO CONTROL THE ITCHING.