MIRADRY SYSTEM
Received Oct 11, 2023 · Event occurred Jan 10, 2023
Report 3008082710-2023-70043 · MDR key 17916637
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
18 YR · Male
- Skin Infection
- Skin Infection
Narrative
Description of Event or Problem
- - 20230110 : PATIENT CONTACTED MIN CLINIC AND SHARED THE CENTER OF THE TREATMENT AREA IN RT. UNDERARM COLOR WAS CHANGED TO BLACKISH AND FOUND A SMALL HOLE, SKIN PEELING AND BLEEDING. - - 20230113 : ASSESSED BY DR.(B)(6) AND PROVIDED WOUND DRESSING. PRESCRIBED CEPA ANTIBIOTICS (VIA IV) + ANTIBIOTICS ORAL MEDICATION. - - 20230118 : SURROUNDING AREA OF PROBLEM AREA IN RT. UNDERARM WAS TURNED TO BLACK AND LT. SIDE OF UNDERARM WAS ALSO TURNED TO BLACKISH. - - 20230119: ASSESSED BY DR.(B)(6) AND PROVIDED WOUND DRESSING. PRESCRIBED CEPA ANTIBIOTICS (VIA IV) + ANTIBIOTICS ORAL MEDICATION. - - 20230210 : PATIENT CONTACTED CLINIC TO SHARE HE IS EXPERIENCING SWELLING, HEAT SENSATION, PAIN WERE STARTED IN LT. UNDERARM. - - 20230211 : ASSESSED BY DR.(B)(6) AND PRESCRIBED CEPA ANTIBIOTICS (VIA IV) + ANTIBIOTICS ORAL MEDICATION. - - 20230428 : PATIENT SENT HIS PHOTO AND FOUND A HOLE IN LT. UNDERARM - - 20230429: ASSESSED BY DR.(B)(6) AND PRESCRIBED CEPA ANTIBIOTICS (VIA IV) + ANTIBIOTICS ORAL MEDICATION. - - 20230831: PATIENT CONTACTED CLINIC TO SHARE THAT THE SAME AREA OF LT. UNDERARM WAS INFLAMED AGAIN, ALSO CAUSING BLOATING AND SEVERE PAIN. - - 20230902 : ASSESSED BY DR.(B)(6) AND PRESCRIBED CEPA ANTIBIOTICS (VIA IV) + ANTIBIOTICS ORAL MEDICATION.