BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-PAK CLEANSING ENEMA SET

    MDR report key: 8144 · Received April 22, 1994

    Report

    Report Number
    8144
    Event Type
    Injury
    Date Received
    April 22, 1994
    Date of Event
    March 29, 1994
    Report Date
    April 8, 1994
    Manufacturer
    GENERAL MEDICAL CO.
    Product Code
    FCE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GENERAL MEDICAL CORP. RECEIVED A RESPONSE FROM THEIR MANUFACTURER, PLASCO, INC CONCERNING THIS UFR REPORT: AS THE MANUFACTURER OF THIS DEVICE, ON MAY 18, 1994 WE ALSO SUBMITTED AN MDR FOR THIS EVENT. OUR INVESTIGATION CLASSIFIED THIS EVENT AS A USER ERROR WITH NO CORRECTIVE ACTION REQUIRED. THE PRINTED DIRECTIONS FOR USE ON THE CARTON REQUIRE REMOVAL OF THE SHEATH FROM PRELUBRICATED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-PAK CLEANSING ENEMA SET ENEMA SET FCE GENERAL MEDICAL CO. NA 4060-493

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention