BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVINA SMART SYSTEM REGULAR

    MDR report key: 12907540 · Received December 1, 2021

    Report

    Report Number
    3009632672-2021-00002
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 14, 2021
    Report Date
    December 1, 2021
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    KNT
    PMA / PMN Number
    K190977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WELLSPECT HEALTHCARE BEEN IN CONTACT WITH THE PATIENT'S HUSBAND, AND RECEIVED INFORMATION STATING THAT THE PATIENT IS RECOVERING AND THAT NO SURGICAL INTERVENTION IS PLANNED. THE PATIENT, WHICH WAS SUFFERING FROM CYTOCELE AND RECTOCELE WAS CAREFULLY INSTRUCTED UNDER WELLSPECT HEALTHCARE SUPERVISION IN HOW TO OPERATE THE NAVINA SMART SYSTEM IN PERFORMING A TRANSANAL IRRIGATION, AND DID SO ACCORDINGLY WITH A GOOD HYGIENE REGIMEN. OUR INVESTIGATION, WITH THE HELP OF THE PATIENT'S HUSBAND AND CLINICIANS, SHOWS THAT THE IRRIGATION WAS NOT THE MAIN CAUSE FOR THE SEPTIC SHOCK. THE PATIENT HAS ALSO STATED THAT THERE WAS NO PRODUCT-ERROR, AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THIS INCIDENT OCCURED IN (B)(6). THE PATIENT WAS INSTRUCTED ON THE 5TH OF NOVEMBER ON HOW TO PERFORM TAI. ON THE 14TH OF NOVEMBER, THE PATIENT WAS SUDDENLY NOT FEELING WELL, AND WAS FOUND THE NEXT DAY UNCONSCIOUS IN THE BATHROOM. THE PATIENT WAS BROUGHT TO THE HOSPITAL, ADMITTED TO THE ICU WHERE VENTILATION AND DIALYSIS WAS PERFORMED ON THE 15TH OF NOVEMBER. THE PATIENT WAS EXTUBATED ON THE 16TH OF NOVEMBER. ON THE 17TH OF NOVEMBER, THE PATIENTS' HANDS AND FEET WERE BLACK, POSSIBLY DUE TO AN INFLAMMATION FROM A GERM. ACCORDING TO THE ATTENDING PHYSICIAN, THE PATIENT HAS A PREVIOUS MEDICAL HISTORY WITH BOTH CYSTOCELE AND RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806989 NAVINA SMART SYSTEM REGULAR GASTROINTESTINAL TUBE AND ACCESSORIES KNT WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 69009 476333

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R| O