BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVINA CLASSIC SYSTEM

    MDR report key: 17486573 · Received August 9, 2023

    Report

    Report Number
    3009632672-2023-00003
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 9, 2023
    Manufacturer
    WELLSPECT AB
    Product Code
    KNT
    PMA / PMN Number
    K190977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. 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

    A 70 YEAR'S OLD FEMALE PATIENT WITH HISTORY OF COLON CANCER TREATED WITH IRRADIATION IN 2012, HAS BEEN PRESCRIBED A NAVINA CLASSIC TRANS ANAL IRRIGATION SYSTEM. THE PATIENT RECEIVED APPROPRIATE INSTRUCTION ON (B)(6) 2023 TO USE THE PRESCRIBED NAVINA CLASSIC SYSTEM WITH RECTAL BALLOON CATHETER. ON (B)(6) 2023 THE PATIENT CONTACTED THE MANUFACTURER SALES REPRESENTATIVE IN GERMANY AS SHE IS LOCATED THERE AND COMPLAINT ABOUT SLIGHT PAINT OR PRESSURE IN LOWER PART OF COLON (ANUS). THE PATIENT WAS REFERRED TO SICK MEDICAL CARE FOR EXAMINATION. AT (B)(6) 2023 SHE (PATIENT) VISITED DOCTOR IN (B)(6) (GERMANY) TO UNDERGO A PROCTOSCOPY EXAMINATION. A SIGMOIDOSCOPY WAS PERFORMED WITHOUT ANY MEDICAL FINDING AND SHE WAS RECOMMENDED TO CONTINUE WITH TAI TREATMENT. ON (B)(6) 2023 PATIENT SUDDENLY GOT PAIN, INTESTINAL BLEEDING, ACUTE ABDOMEN, AND PAIN SPASTICITY IN LEGS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND HER DOCTOR PERFORMED A NEW RECTOSCOPY, WHICH SHOWED A SLIGHT MUCOSAL INJURY. 3-4H LATER THE PATIENT HAD AIR AND FLUID ACCUMULATION IN THE PELVIS. ON (B)(6) 2023 THE PATIENT UNDERWENT A SURGERY IN WHICH PART OF RECTUM WAS REMOVED AND AN ANUS PRAETER WAS CREATED. ACCORDING TO THE COMPLAINT THIS SURGERY WAS DISCUSSED WITH THE PATIENT BEFORE SHE WAS PRESCRIBED A TRANS ANAL IRRIGATION, BUT SHE WAS RECOMMENDED TO TRY TAI FIRST BEFORE DECIDING TO HAVE AN AP APPENDIX. BY THE DATE OF THIS INCIDENT THE HISTOLOGY RESULT OF THE SURGERY IS STILL PENDING. ON (B)(6) 2023 THE FEMALE PATIENT DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543436 NAVINA CLASSIC SYSTEM NAVINA CLASSIC SYSTEM REGULAR KNT WELLSPECT AB 69005 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization