InjuryOUB
MIRADRY SYSTEM
Received Mar 2, 2022 · Event occurred Jun 1, 2021
Report 3008082710-2022-70002 · MDR key 13656732
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
- Skin Disorders
- Skin Disorders
Narrative
Additional Manufacturer Narrative
A REVIEW OF DATA ON THE SYSTEM INDICATED NOTHING OUT OF THE ORDINARY.
Description of Event or Problem
THE DOCTOR REPORTED THAT A PATIENT HE TREATED IN (B)(6) 2021 DEVELOPED ONGOING KELOID SCARS W/GRANULE TYPE CYSTS BENEATH THAT OOZE AND NEED TO BE DRAINED, VERY MUCH LIKE A PRESENTATION OF HS. THE DOCTOR HAS BEEN INJECTING WITH STEROIDS BUT PATIENT HAS NOT SEEN MUCH IMPROVEMENT.
Remedial action
- Other