INNOVO, TYPE NUMBER 207

Description of Event or Problem

RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. CUSTOMER BASED IN THE UNITED KINGDOM CONTACTED THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM ON THE (B)(6) 2021 REPORTING SHE HAS BEEN EXPERIENCED UNCOMFORTABLE SENSATIONS IN AND AROUND HER HEART AND CHEST AREA - "FLUTTERING AND VERY LIGHT-HEADEDNESS" AND "EYES BLURRING" AFTER 3 USES OF THE DEVICE. NO ERROR CODES WERE REPORTED DURING USE OF THE DEVICE. IN LINE WITH THE INSTRUCTIONS FOR USE, THE CUSTOMER CEASED USE OF THE DEVICE AND RETURNED TO ATLANTIC THERAPEUTICS FOR FURTHER INVESTIGATION. THERE IS NO REPORTED INJURY OR HARM TO THE CUSTOMER. VIGILANCE REPORTING WAS DEEMED NOT REQUIRED. ADDITIONAL INFORMATION PROVIDED FROM THE CUSTOMER INCLUDES THE FOLLOWING THOUGH NOT RELATED TO USE OF THE INNOVO DEVICE: THE CUSTOMER HAS PROVIDED THEIR MEDICAL HISTORY AND ADVISED THEY HAD UNDERGONE CANCER TREATMENT END 2019/EARLY 2020. THEY UNDERWENT SURGERY IN (B)(6) 2019 THEN RADIOTHERAPY (B)(6) 2020. THE CUSTOMER ALSO TAKES ANASTROZOLE TABLETS DAILY. THE INNOVO DEVICE WAS RETURNED ON THE (B)(6) 2021 AND INSPECTED FOR DEFECTS.THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED BEYOND ITS CAPACITY TO FUNCTION. THIS EVENT REMAINS NON-REPORTABLE AND IS REPORTED TO FDA ON REQUEST DUE TO SIMILAR EVENT.

Description of Event or Problem

FINAL REPORT SUBMITTED WITH NO ADDITIONAL INFORMATION. RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. CUSTOMER BASED IN THE UNITED KINGDOM CONTACTED THE ATLANTIC THERAPEUTICS CUSTOMER CARE TEAM ON THE 05TH JANUARY 2021 REPORTING SHE HAS BEEN EXPERIENCED UNCOMFORTABLE SENSATIONS IN AND AROUND HER HEART AND CHEST AREA - "FLUTTERING AND VERY LIGHT-HEADEDNESS" AND "EYES BLURRING" AFTER 3 USES OF THE DEVICE. NO ERROR CODES WERE REPORTED DURING USE OF THE DEVICE. IN LINE WITH THE INSTRUCTIONS FOR USE, THE CUSTOMER CEASED USE OF THE DEVICE AND RETURNED TO ATLANTIC THERAPEUTICS FOR FURTHER INVESTIGATION. THERE IS NO REPORTED INJURY OR HARM TO THE CUSTOMER. VIGILANCE REPORTING WAS DEEMED NOT REQUIRED. ADDITIONAL INFORMATION PROVIDED FROM THE CUSTOMER INCLUDES THE FOLLOWING THOUGH NOT RELATED TO USE OF THE INNOVO DEVICE: THE CUSTOMER HAS PROVIDED THEIR MEDICAL HISTORY AND ADVISED THEY HAD UNDERGONE CANCER TREATMENT END 2019/EARLY 2020. THEY UNDERWENT SURGERY IN (B)(6) 2019 THEN RADIOTHERAPY (B)(6) 2020. THE CUSTOMER ALSO TAKES ANASTROZOLE TABLETS DAILY. THE INNOVO DEVICE WAS RETURNED ON THE 25TH JANUARY 2021 AND INSPECTED FOR DEFECTS. THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED BEYOND ITS CAPACITY TO FUNCTION. THIS EVENT REMAINS NON-REPORTABLE AND IS REPORTED TO FDA ON REQUEST DUE TO SIMILAR EVENT.