BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVO, TYPE NUMBER 208

    MDR report key: 17451748 · Received August 3, 2023

    Report

    Report Number
    3015223097-2023-00011
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    May 12, 2021
    Report Date
    August 2, 2023
    Manufacturer
    ATLANTIC THERAPEUTICS LTD
    Product Code
    QAJ
    PMA / PMN Number
    K192357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FINAL REPORT SUBMITTED WITH NO ADDITIONAL INFORMATION. RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON 17TH MAY 2021 WITH TRANSIENT NUMBNESS OF THE LEFT LEG FOLLOWED BY CHEST PAIN RESOLVED WITHIN 3 - 5 MINUTES FROM DEEP BREATHING. NO REPORTED LONG TERM HEALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER REPORTED A MEDICAL HISTORY OF BREAST CANCER WITH LYMPECTOMY RADIATION AND CHEMOTHERAPY. CUSTOMER ALSO REPORTED VARICOSE VEINS IN THE CALF AREA AND LEGS. THE INNOVO DEVICE WAS RETURNED ON THE 26TH MAY 2021 AND INSPECTED FOR DEFECTS ON THE 14TH MARCH 2022 .THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.

    Description of Event or Problem · 0

    RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON (B)(6) 2021 WITH TRANSIENT NUMBNESS OF THE LEFT LEG FOLLOWED BY CHEST PAIN RESOLVED WITHIN 3 - 5 MINUTES FROM DEEP BREATHING. NO REPORTED LONG TERM HEALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER REPORTED A MEDICAL HISTORY OF BREAST CANCER WITH LYMPECTOMY RADIATION AND CHEMOTHERAPY. CUSTOMER ALSO REPORTED VARICOSE VEINS IN THE CALF AREA AND LEGS. THE INNOVO DEVICE WAS RETURNED ON THE (B)(6) 2021 AND INSPECTED FOR DEFECTS ON THE (B)(6) 2022 .THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470303 INNOVO, TYPE NUMBER 208 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPEUTICS LTD 208 20190706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female