InjuryOUB
MIRADRY SYSTEM
Received Feb 10, 2021 · Event occurred Jun 1, 2020
Report 3008082710-2021-00002 · MDR key 11311003
Device
Generic name
Microwave Dermatologic System
Manufacturer
Sientra, Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
18H0486-JP
Product problems
- Patient-Device Incompatibility
Patient
44 YR
- Unspecified Infection
- Skin Irritation
- Unspecified Infection
- Skin Irritation
Narrative
Description of Event or Problem
PATIENT RECEIVED MIRADRY TREATMENT (B)(6) 2020 AND SUBSEQUENTLY WAS DIAGNOSED WITH A WOUND INFECTION AT THE CLINIC ON (B)(6) 2020. ON THAT SAME DAY ANTIBIOTICS WERE ADMINISTERED BOTH TOPICALLY AND VIA INTRAVENOUS FEEDING. THE PATIENT WAS LATER DIAGNOSED AS HAVING SKIN IRRITATION FROM HIDRADENITIS SUPPURATIVA AND THE TREATMENT.