INNOVO, TYPE NUMBER 207

Description of Event or Problem

FOLLOW UP - ADDITIONAL INFORMATION INSUFFICIENT INFORMATION. NO DEFECT FOUND. CUSTOMER INFORMED ATLANTIC THERAPEUTICS THAT THEY HAVE USED THE PRODUCT FOR 3 MONTHS AS PRESCRIBED AND EXPERIENCED PAINFUL SCIATICA. THE CUSTOMER WENT TO A PHYSIOTHERAPIST WHO PROVIDED THE CUSTOMER WITH DAILY EXERCISES TO COMPLETE. TREATMENT HAS BEEN ONGOING FOR 12 MONTHS AND CUSTOMER HAS INFORMED US THAT THEY MAY HAVE TO CONTINUE TREATMENT FOR SEVERAL YEARS DUE TO THE SEVERITY OF THE PAIN EXPERIENCED. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR FURTHER EVALUATION. MEDICAL QUESTIONNAIRE RECEIVED 02ND AUGUST 2023. CUSTOMER REPORTED AFTER USING THE DEVICE FOR SEVERAL WEEKS THEY BEGAN EXPERIENCING SHOOTING PAINS IN THEIR HIP, WHICH RADIATED DOWN THEIR LEG AND AT TIMES AFFECTING THEIR FOOT. THE PAIN IMPACTED THE CUSTOMERS ABILITY TO STAND AND WALK. THE CUSTOMER PHYSICIAN ADVISED THEM TO TAKE TO PARACETAMOL AND IBUPROFEN TO MANAGE THEIR PAIN AND REFERRED THE CUSTOMER FOR PHYSIOTHERAPY. THE CUSTOMER HAS EXPERIENCED "A FEW FLAIR UPS" SINCE THE EVENT OCCURRED. ADDITIONAL INFORMATION: THE INNOVO DEVICE WAS RETURNED TO (B)(6), IRELAND ON THE 17TH AUGUST 2023. NO DEVICE DEFECTS WERE FOUND UPON VISUAL INSPECTION.

Additional Manufacturer Narrative

ATLANTIC THERAPEUTICS HAVE REQUESTED THE DEVICE TO BE RETURNED, IT IS ANTICIPATED THE DEVICE WILL BE RETURNED BUT NOT YET RECEIVED AS OF 09-AUG-2023. ADEQUATE TRACEABILITY INFORMATION HAS NOT BEEN PROVIDED TO DATE FROM THE CUSTOMER/USER. FULL TRACEABILITY INFORMATION CANNOT BE ASCERTAINED.

Description of Event or Problem

INSUFFICIENT INFORMATION. NO DEFECT FOUND. CUSTOMER INFORMED ATLANTIC THERAPEUTICS THAT THEY HAVE USED THE PRODUCT FOR 3 MONTHS AS PRESCRIBED AND EXPERIENCED PAINFUL SCIATICA. THE CUSTOMER WENT TO A PHYSIOTHERAPIST WHO PROVIDED THE CUSTOMER WITH DAILY EXERCISES TO COMPLETE. TREATMENT HAS BEEN ONGOING FOR 12 MONTHS AND CUSTOMER HAS INFORMED US THAT THEY MAY HAVE TO CONTINUE TREATMENT FOR SEVERAL YEARS DUE TO THE SEVERITY OF THE PAIN EXPERIENCED. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR FURTHER EVALUATION. MEDICAL QUESTIONNAIRE RECEIVED (B)(6) 2023. CUSTOMER REPORTED AFTER USING THE DEVICE FOR SEVERAL WEEKS THEY BEGAN EXPERIENCING SHOOTING PAINS IN THEIR HIP, WHICH RADIATED DOWN THEIR LEG AND AT TIMES AFFECTING THEIR FOOT. THE PAIN IMPACTED THE CUSTOMERS ABILITY TO STAND AND WALK. THE CUSTOMER PHYSICIAN ADVISED THEM TO TAKE TO PARACETAMOL AND IBUPROFEN TO MANAGE THEIR PAIN AND REFERRED THE CUSTOMER FOR PHYSIOTHERAPY. THE CUSTOMER HAS EXPERIENCED "A FEW FLAIR UPS" SINCE THE EVENT OCCURRED.

Additional Manufacturer Narrative

ATLANTIC THERAPEUTICS HAVE REQUESTED THE DEVICE TO BE RETURNED ON NUMEROUS OCCASIONS, WITHOUT SUCCESS AND AS OF 14 JUL 2023 CAN CONFIRM THAT THERE IS NO RESPONSE FROM THE CUSTOMER. ADEQUATE TRACEABILITY INFORMATION HAS NOT BEEN PROVIDED TO DATE FROM THE CUSTOMER/USER. FULL TRACEABILITY INFORMATION CANNOT BE ASCERTAINED.

Description of Event or Problem

CUSTOMER INFORMED ATLANTIC THERAPEUTICS THAT THEY HAVE USED THE PRODUCT FOR 3 MONTHS AS PRESCRIBED AND EXPERIENCED PAINFUL SCIATICA. THE CUSTOMER WENT TO A PHYSIOTHERAPIST WHO PROVIDED THE CUSTOMER WITH DAILY EXERCISES TO COMPLETE. TREATMENT HAS BEEN ONGOING FOR 12 MONTHS AND CUSTOMER HAS INFORMED US THAT THEY MAY HAVE TO CONTINUE TREATMENT FOR SEVERAL YEARS DUE TO THE SEVERITY OF THE PAIN EXPERIENCED. THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER FOR FURTHER EVALUATION, DESPITE MULTIPLE ATTEMPTS BY ATLANTIC THERAPEUTICS TO SECURE THE PRODUCT.