BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT INTRODUCER PEG 20FR PULL METHOD SAFETY MIC KEY LOW PROFILE TUBE

    MDR report key: 21699713 · Received March 26, 2025

    Report

    Report Number
    MW5168243
    Event Type
    Death
    Date Received
    March 26, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 20, 2025
    Manufacturer
    AVANOS MEDICAL / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT'S PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) WAS REMOVED AND REPLACED WITH A MICKEY BUTTON PER PROTOCOL WITHOUT COMPLICATION (MORE FORCE THAN USUAL WAS NEEDED, HOWEVER). PATIENT TOLERATED THIS WELL. THE PATIENT'S CAREGIVER CALLED LATER, STATING THE PATIENT WAS HAVING PAIN AND LOOKED PALE. PER REVIEW OF THE NOTES, THE PATIENT WAS EVALUATED AT HIS LOCAL ER AND THEN ADMITTED TO HIS LOCAL HOSPITAL FOR CONTINUED CARE AND TREATMENT. A CT SCAN REVEALED FINDINGS CONSISTENT WITH TUBE FEEDINGS WITHIN THE ABDOMINAL CAVITY. THE PATIENT DEVELOPED SEPSIS AND PERITONITIS AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785881 KIT INTRODUCER PEG 20FR PULL METHOD SAFETY MIC KEY LOW PROFILE TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 10237122

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other| D