InjuryOUB
MIRADRY SYSTEM
Received Jun 22, 2022
Report 3008082710-2022-70022 · MDR key 14782044
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Numbness
- Numbness
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE TREATMENT DATA ON (B)(6) 2021 DID NOT FIND ANY USUAL PERFORMANCE OR ERRORS. THE SYSTEM WAS FUNCTIONING NORMALLY DURING THE (B)(6) 2021.
Description of Event or Problem
PATIENT HAS ONGOING NERVE RELATED INJURY FROM ELBOW TO HAND PATIENT HAS EXAM, PT HAS FULL MOBILITY AND FUNCTION. REPORTS PULLING AND TIGHTNESS. PATIENT IS FOLLOWING UP WITH AN ORTHOPEDIC SURGEON FOR TESTING.