FDA Adverse Event Injury Summary report: N

MIRADRY SYSTEM

MDR report key: 3152518 · Received June 4, 2013

Report

Report Number
3008082710-2013-00003
Event Type
Injury
Date Received
June 4, 2013
Date of Event
April 16, 2013
Report Date
May 8, 2013
Manufacturer
MIRAMAR LABS INC.
Product Code
OUB
PMA / PMN Number
K103014
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PATIENT RECEIVED FIRST MIRADRY TREATMENT ON (B)(6) 2013. SHAVED 2 DAYS BEFORE WITH ELECTRIC RAZOR, SKIN LOOKED NORMAL AT TREATMENT TIME. PATIENT CALLED CLINIC ON OR ABOUT ON (B)(6) 2013, WITH SOME SWELLING. PHYSICIAN PRESCRIBED A STEROID DOSE PACK PER THEIR USUAL PRACTICE IN THIS CLINIC. PATIENT CALLED CLINIC TO REPORT PAINFUL NODULES ONE WEEK LATER. PATIENT ASSESSED ON (B)(6) 2013. LARGE (COUPLE OF CM), BILATERAL, RED INFLAMED NODULES WITH SUPERFICIAL EROSION OVER BOTH. CLEANED AND USED 20G NEEDLE TO TRY AND WITHDRAW FLUID. NO SIGNIFICANT FLUID OR PUS. PRESCRIBED ANTIBIOTIC (DOXYCYCLINE). PATIENT CALLED CLINIC ON (B)(6) 2013, WITH REDNESS AND TIGHT SKIN IN UPPER ARM. ADVISED TO GO TO ER BECAUSE IT WAS POTENTIALLY CELLULITIS. WAS ADMITTED FOR OVERNIGHT OBSERVATION (1 NIGHT) AND GIVEN IV CLYNDAMYCIN. PHYSICIAN VISITED PATIENT ON (B)(6) 2013 AND PATIENT WAS FEELING BETTER AND DISCHARGED. PHYSICIAN SAW PATIENT ON (B)(6) 2013, WITH CONTINUED IMPROVEMENT. ON (B)(6) 2013, THE NODULES WERE STILL THERE AND EROSIONS WERE CRUSTING. ON (B)(6) 2013, PHYSICIAN REPORTED THE FOLLOWING: I JUST SPOKE WITH HIM. HE IS DOING MUCH BETTER. NO PAIN OR SWELLING. THE CELLULITIS RESOLVED AND HE IS OFF ORAL ANTIBIOTICS. HE IS STILL USING MUPIROCEN OINTMENT DAILY AS A PRECAUTION BECAUSE HE SAYS HE STILL HAS THE PINK NODULES WITH OVERLYING SCAB WHICH IS NOT HEALED YET BUT IS OVERALL BETTER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
247143 MIRADRY SYSTEM OUB MIRAMAR LABS INC. MD4000-MC 11H0339

Patients

Seq Age Sex Outcome Treatment
1 25 YR Required Intervention