BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO, TYPE NUMBER 208

    MDR report key: 18901373 · Received March 14, 2024

    Report

    Report Number
    3015223097-2024-00001
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    May 1, 2023
    Report Date
    March 12, 2024
    Manufacturer
    ATLANTIC THERAPETUCIS
    Product Code
    QAJ
    PMA / PMN Number
    K192357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION OF THE RETURNED DEVICE, THE CONTROLLER WAS ASSESSED AND IT WAS OBSERVED THAT NO TREATMENT SESSIONS WERE RECORDED, THEREFORE THE SHORTS AND DEVICE WERE NOT USED BY THE CUSTOMER. THE ADVERSE EVENT REPORTED BY THE CUSTOMER IS NOT RELATED TO THE USE OF THE INNOVO DEVICE.

    Description of Event or Problem · 0

    IN MAY 2023 THE CUSTOMER EXPERIENCED TIA (TRANSIENT ISCHEMIC ATTACK). IT IS UNKNOWN AT THIS POINT IN TIME IF THE CUSTOMER EXPERIENCED THE TIA DURING TREATMENT. CUSTOMER SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO CEASE USE OF THE DEVICE IMMEDIATELY. CUSTOMER PROVIDED A PHYSICIAN LETTER CONFIRMING THE CUSTOMER IS CONTRAINDICATED DUE TO PRE EXISTING MEDICAL PROBLEMS THAT EXISTED BEFORE PURCHASE OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID WITH THE INVESTIGATION AND ANY INFORMATION RECEIVED WILL BE INCLUDED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 0

    FINAL REPORT SUBMITTED - RETURN DEVICE EVALUATION. IN (B)(6) 2023 THE CUSTOMER EXPERIENCED TIA (TRANSIENT ISCHEMIC ATTACK). IT IS UNKNOWN AT THIS POINT IN TIME IF THE CUSTOMER EXPERIENCED THE TIA DURING TREATMENT. CUSTOMER SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO CEASE USE OF THE DEVICE IMMEDIATELY. CUSTOMER PROVIDED A PHYSICIAN LETTER CONFIRMING THE CUSTOMER IS CONTRAINDICATED DUE TO PRE EXISTING MEDICAL PROBLEMS THAT EXISTED BEFORE PURCHASE OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID WITH THE INVESTIGATION AND ANY INFORMATION RECEIVED WILL BE INCLUDED IN THE FOLLOW UP REPORT. FINAL REPORT COMMENTS: CUSTOMER WAS CONTACTED BY THE CUSTOMER CARE TEAM ON (B)(6) 2024 AND (B)(6) 2024 REQUESTING ADDTIONAL INFORMATION TO AID THE INVESTIGATION HOWEVER NO RESPONSE HAS BEEN RECEIVED AS OF (B)(6) 2024. THE INNOVO SHORTS AND CONTROLLER WERE RETURNED TO GALWAY, IRELAND ON THE 27TH MAR 2024 AND INSPECTED FOR DEFECTS. THE INNOVO SHORTS PASSED VISUAL INSPECTION. THE CONTROLLER WAS ASSESSED AND IT WAS OBSERVED THAT NO TREATMENT SESSIONS WERE RECORDED, THEREFORE THE SHORTS AND DEVICE WERE NOT USED BY THE CUSTOMER. THE ADVERSE EVENT REPORTED BY THE CUSTOMER IS NOT RELATED TO THE USE OF THE INNOVO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093105 INNOVO, TYPE NUMBER 208 CUTANEOUS ELECTRODE STIMULATOR FOR URINARY INCONTINENCE QAJ ATLANTIC THERAPETUCIS 208 2200008BO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R