FDA Adverse Event Injury Summary report: N

VISICA 2 TREATMENT SYSTEM

MDR report key: 5739802 · Received June 21, 2016

Report

Report Number
3008087395-2016-00002
Event Type
Injury
Date Received
June 21, 2016
Date of Event
May 13, 2016
Report Date
June 21, 2016
Manufacturer
SANARUS TECHNOLOGIES INC.
Product Code
GEH
PMA / PMN Number
K062896
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

A CALL WAS RECEIVED FROM A PATIENT EXPLAINING THAT SHE WAS TREATED WITH THE VISICA 2, CRYOABLATION FOR HER BREAST TUMOR AND WAS TOLD BY THE PHYSICIAN THAT SHE WOULD BE COMPLETELY HEALED IN TWO WEEKS. AFTER TWO WEEKS SHE IS EXPERIENCING PAIN, SWELLING, AND DRAINAGE. IN COMMUNICATING WITH THE FACILITY SHE WAS FIRST TOLD TO USE ANTIBIOTIC OINTMENT, BUT IT GOT WORSE. THE PATIENT'S PRIMARY CARE PHYSICIAN IS NOT FAMILIAR WITH CRYOABLATION AND CALLED THE MANUFACTURER ASKING FOR A REFERRAL OF A DOCTOR IN HER AREA FAMILIAR WITH CRYOABLATION. A CONSULTATION SESSION WAS SETUP WITH A PHYSICIAN KNOWLEDGEABLE WITH CRYOABLATION. IN THE MEANTIME HER PRIMARY CARE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR HER SYMPTOMS. ON (B)(6) 2016 THE PATIENT CALLED TO REPORT THAT SHE WAS DOING MUCH BETTER AND HER BREAST IS NO LONGER PAINFUL, THE DRAINAGE HAS SUBSIDED AND THE SWELLING IS ALMOST COMPLETELY DOWN. SHE DID NOT CONSULT WITH THE REFERRAL CRYOABLATION PHYSICIAN BECAUSE SHE IS FEELING BETTER AND SIMPLY RE-FOCUSED ON HER ONGOING TREATMENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
394231 VISICA 2 TREATMENT SYSTEM CRYOABLATION SYSTEM GEH SANARUS TECHNOLOGIES INC. VS3000

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention