BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO, TYPE NUMBER 207

    MDR report key: 17324096 · Received July 14, 2023

    Report

    Report Number
    3015223097-2023-00009
    Event Type
    Injury
    Date Received
    July 14, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ATLANTIC THERAPEUTICS LTD
    Product Code
    QAJ
    PMA / PMN Number
    K192357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207744 INNOVO, TYPE NUMBER 207 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LTD 207 1700058VM / 1700059VM

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention