BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ENDOSCOPIC OVERTUBE

    MDR report key: 101736 · Received June 25, 1997

    Report

    Report Number
    1223688-1997-00013
    Event Type
    Injury
    Date Received
    June 25, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 5, 1997
    Manufacturer
    BIPD, DIV. C.R. BARD
    Product Code
    KOG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    H10 - PRESENCE OF ADHESIVE NOTED. UNK IF CUSTOMER USED PRODUCT BEYOND THE RECOMMENDED 25X STATED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    RISK MGMT STATES RN INDICATED OUTPATIENT CAME INTO FACILITY FOR ESOPHAGEAL LIGATION PROCEDURE. DURING BANDING PROCEDURE WITH BARD BITE BLOCK IN PLACE THE PHY. REMOVED UNK SCOPE FROM PT. AND NOTED THE OVERTUBE HAD SEPARATED COMPLETELY FROM MOUTHPIECE PORTION OF OVERTUBE AND REMAINED IN PT'S ESOPHAGUS USING BALLOON DILATOR MD WAS ABLE TO REMOVE TUBE AND A MUCOSAL TEAR WAS NOTED. S

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ENDOSCOPIC OVERTUBE OVERTUBE KOG BIPD, DIV. C.R. BARD 61 000230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R