BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTAFLO BOWEL CATHETER SYSTEM

    MDR report key: 5089519 · Received September 18, 2015

    Report

    Report Number
    1480288-2015-00004
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    July 4, 2015
    Report Date
    September 18, 2015
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    KNT
    PMA / PMN Number
    K123804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 WITH A GUNSHOT WOUND TO THE ABDOMEN REQUIRING BOWEL RESECTION AND ILIAC ARTERY REPAIR. THE INSTAFLO BOWEL CATHETER DEVICE WAS INSERTED ON (B)(6) 2015 AND REMOVED ON (B)(6) 2015. ON (B)(6), 2 LITERS OF BRIGHT RED BLOOD PER RECTUM WERE NOTED. ON (B)(6), ONE LITER OF BLOOD PER RECTUM WAS OBSERVED. THE PATIENT RECEIVED AT LEAST 2 UNITS OF BLOOD PRODUCTS. ON (B)(6) A COLONOSCOPY WAS PERFORMED AND A RECTAL ULCER WITH A LARGE CLOT WAS OBSERVED AT ABOUT THE LOCATION WHERE THE INSTAFLO RETENTION CUFF WOULD HAVE BEEN LYING. THE BLEED WAS CLIPPED WITH A HEMOSTATIC CLIP; NO ADDITIONAL BLEEDING WAS OBSERVED. PATIENT REMAINS HOSPITALIZED FOR INITIAL ADMISSION REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617584 INSTAFLO BOWEL CATHETER SYSTEM INSTAFLO BOWEL CATHETER KNT HOLLISTER INCORPORATED 33016

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention