BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-USE SALIVA EJECTORS

    MDR report key: 36163 · Received August 22, 1996

    Report

    Report Number
    36163
    Event Type
    Injury
    Date Received
    August 22, 1996
    Date of Event
    August 15, 1996
    Report Date
    August 19, 1996
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS, INC.
    Product Code
    DYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETION OF ENDOSCOPY PROCEDURE AND REMOVAL OF SCOPE, PT WAS SUCTIONED ORALLY WITH A SALIVA EJECTOR. UPON REMOVAL OF THE SALIVA EJECTOR FROM THE MOUTH, IT WAS NOTED THAT THE BLUE TOP OF THE SALIVA EJECTOR WAS MISSING. STAFF UNABLE TO LOCATE BLUE TIP DIGITALLY IN PT ORAL CAVITY. PHYSICIAN PRESENT AND RE-SEDATED PT AND PT RE-ENDOSCOPED AND BLUE TIP NOTED IN PROXIMAL ESOPHAGUS. PHYSICIAN ADVANCED BLUE TIP INTO STOMACH WHERE IT WAS RETRIEVED WITH THE ROTH NET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE-USE SALIVA EJECTORS SINGLE-USE SALIVA EJECTORS DYN JOHNSON & JOHNSON CONSUMER PRODUCTS, INC. NA 9075

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention