BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWER PEG TUBE

    MDR report key: 33733 · Received May 3, 1996

    Report

    Report Number
    33733
    Event Type
    Injury
    Date Received
    May 3, 1996
    Date of Event
    March 22, 1996
    Report Date
    March 28, 1996
    Manufacturer
    CORPAK CO.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE INSERTED ON 3/18/96 USING THE PULL TECHNIQUE. DEVELOPED LEAKAGE AND CELLULITIS AROUND TUBE SITE. THE PHYSICIAN STATED THAT THE BOLSTER HAD MALFUNCTIONED AND THE TUBE SUBSEQUENTLY BECAME LAX/DISLODGED ALLOWING LEAKAGE AROUND THE TUBE AND INTO THE SUBCUTANEOUS TISSUE CAUSING THE CELLULITIS. THE TUBE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWER PEG TUBE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE KNT CORPAK CO. 20FR

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention