InjuryOUB
MIRADRY SYSTEM
Received Apr 28, 2021 · Event occurred Dec 18, 2020
Report 3008082710-2021-00003 · MDR key 11740403
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
UNKNOWNCatalog number
UNKNOWN
Lot number
20H0001
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
35 YR
- Erythema
- Necrosis
- Post Operative Wound Infection
- Swelling/ Edema
- Erythema
- Necrosis
- Post Operative Wound Infection
- Swelling/ Edema
Narrative
Description of Event or Problem
ON (B)(6) 2020 PATIENT FEELING TENDER AND SWELLING PRESENT . ON (B)(6) 2020 PATIENT HAD REDNESS, SWELLING AND TENDERNESS. ON (B)(6) 2020 SYMPTOMS WORSEN. ON (B)(6) 2020 DIAGNOSED WITH INFECTED WOUND AND NECROSIS. PATIENT ADMITTED TO HOSPITAL FOR WOUND DEBRIDEMENT.