BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS PREMIUM COMBINATION DOUCHE AND ENEMA

    MDR report key: 7010255 · Received November 8, 2017

    Report

    Report Number
    0002183416-2017-00001
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 1, 2017
    Report Date
    October 4, 2017
    Manufacturer
    APOTHECARY PRODUCTS, LLC
    Product Code
    FCE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENEMA PIPE WAS INCORRECTLY ATTACHED TO THE TUBING WITHOUT THE ADAPTER. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE ENEMA PIPE WAS INCORRECTLY ATTACHED TO THE TUBING WITHOUT THE ADAPTER. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    USER STATED THAT WHILE USING THE ENEMA, THE TIP CAME LOOSE AND WENT INSIDE OF HER. USER WENT TO THE EMERGENCY ROOM WHERE THEY DID AN X-RAY AND GAVE HER MORPHINE BEFORE THEY WERE FINALLY ABLE TO RETRIEVE IT.

    Description of Event or Problem · 1

    USER STATED THAT WHILE USING THE ENEMA, THE TIP CAME LOOSE AND WENT INSIDE OF HER. USER WENT TO THE EMERGENCY ROOM WHERE THEY DID AN X-RAY AND GAVE HER MORPHINE BEFORE THEY WERE FINALLY ABLE TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789964 WALGREENS PREMIUM COMBINATION DOUCHE AND ENEMA DOUCHE AND ENEMA FCE APOTHECARY PRODUCTS, LLC 02806WG 322KB04

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R