MIRADRY SYSTEM

Description of Event or Problem

PT HAD SLIGHT INGROWN HAIR ON THE LEFT SIDE ON THE TREATMENT DATE. NO SIGNS OF INFECTION OR ERYTHEMA. PATIENT CAME IN ON (B)(6) 2022, WITH A SMALL, SLIGHTLY TENDER NODULE. THE TREATING PHYSICIANS OFFICE ADVISED THE PATIENT TO MASSAGE WITH HEAT AND CONTACT IF WORSENS. PATIENT CAME IN ON (B)(6) 2022 WITH SIGNIFICANT INFLAMMATION, EDEMA, HYPERPIGMENTATION, AND 2 ABSCESSES HAD FORMED. THE PA DID AN IRRIGATION AND DEBRIDEMENT, ANTIBIOTICS WERE GIVEN, AND THE WOUND IS PACK AND CLEAN DAILY. AS OF ON (B)(6) 2022, THE ISSUE IS RESOLVING, BUT NOT FULLY RESOLVED.

Additional Manufacturer Narrative

A 60X100 TEMPLATE WAS USED FOR BOTH THE LEFT AND RIGHT AXILLA. THE 60X100 TEMPLATE HAS 21 PLACEMENTS AND THE (B)(6) 2021 TREATMENT HAD 42 PLACEMENTS SO NO DOUBLE PASSED OCCURRED. ON PLACEMENT L:5A AN E07 (POWER ABORT ERROR) OCCURRED WITH NO ACCOMPANYING ERRORS. SINCE THERE WERE NO ACCOMPANYING ERRORS IT IS LIKELY THAT THE HANDPIECE BUTTON WAS PRESSED IN THE MIDDLE OF THIS PLACEMENT. PLACEMENT L:4A AND L4:B HAD INSTANCES WHERE THE VACUUM PUMP NEEDED TO TURN BACK ON DUE TO A LOSS OF VACUUM HOWEVER THE VACUUM WAS VERY NEAR THE -20 INCHES OF MERCURY ON L:4B AND STILL RIGHT AT -20INCHES OF MERCURY ON PLACEMENT L:4A MEANING THE VACUUM PUMP WAS STILL ABLE TO MAINTAIN THE CORRECT VACUUM WITH THE VACUUM LEAK. SINCE THE VACUUM LEVEL WAS ABLE TO BE MAINTAINED, IT IS UNLIKELY THE VACUUM LEAK IN THE TWO PLACEMENTS HAD ANY EFFECT ON THE TREATMENT. NO ADDITIONAL ISSUES WERE FOUND.