MIRADRY SYSTEM
Received Dec 23, 2020 · Event occurred Nov 17, 2020
Report 3008082710-2020-00035 · MDR key 11069824
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
MN-MD4000-MC-GBCatalog number
MN-MD4000-MC-GB
Lot number
16H0135
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
30 YR
- Nerve Damage
- Numbness
- Nerve Damage
- Numbness
Narrative
Additional Manufacturer Narrative
THE RATE SEEN ((B)(4)) IS APPROXIMATELY (B)(4) OF THE PROCEDURES AND WITHIN THE ACCEPTABLE RANGE AS IDENTIFIED IN RISK ANALYSIS DOCUMENTATION.
Description of Event or Problem
AFTER TREATMENT TO THE LEFT SIDE, PATIENT PUT ARM DOWN AND REPORTED NUMBNESS TO HAND AND FOREARM, NO PAIN/BLANCHING. PATIENT WAS ADVISED TO CONTINUE MOVING ARM/HAND, ETC. MIRADRY TREATMENT COMPLETED, ONE WEEK POST TREATMENT PATIENT STILL REPORTS NO FEELING IN LEFT HAND. PATIENT DIAGNOSED WITH MEDIAN NERVE INJURY AND REFERRED TO NEUROPHYSIOLOGIST. SYMPTOMS ARE RESOLVING.