MIRADRY SYSTEM
Received Mar 2, 2022 · Event occurred Dec 8, 2021
Report 3008082710-2022-70003 · MDR key 13656734
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
30 YR · Female
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
PER DEVICE DATA INVESTIGATION: THE 60X120 TEMPLATE WAS USED ON BOTH AXILLA. THE 60X120 TEMPLATE HAS 24 PLACEMENTS. THE (B)(6)2021 TREATMENT HAS 48 TOTAL PLACEMENTS WHICH SUGGESTS NO DOUBLE PLACEMENTS OCCURRED. NO A16 OVER TEMP ERRORS OCCURRED DURING THE TREATMENT AND ALL COOLING PLATE TEMPERATURES ARE NORMAL. THERE WERE 188 INSTANCES OF Z16 ADC GLITCH ERRORS, THESE ARE LOG ONLY ERRORS AND APPEAR TO BE ASSOCIATED WITH THE OUTFLOW WATER TEMPERATURE. THE OUTFLOW READINGS ARE NO LONGER USED DURING THE TREATMENT SO THIS WOULD NOT HAVE ANY AFFECT ON THE TREATMENT. PRIOR TO THE TREATMENT, 9 A17 ERRORS OCCURRED DURING THE POST TEST. FROM THE MICROWAVE RETURN POWER PLOTS, IT APPEARS THAT THE COOLING PLATE WAS NOT MAKING GOOD CONTACT WITH THE ECCOSORB PAD OF THE HOLSTER. THE 10TH POST WAS NORMAL AS WERE THE RETURN POWER PLOTS.
Description of Event or Problem
ON (B)(6), THE PATIENT GOT A BURN AFTER THE TREATMENT. THE PATIENT WAS TREATED WITH DELMOBATE OINTMENT.
Remedial action
- Replace