BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALKMED

    MDR report key: 6458715 · Received April 4, 2017

    Report

    Report Number
    1723533-2017-00005
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    February 21, 2017
    Report Date
    April 4, 2017
    Manufacturer
    WALKMED INFUSION, LLC
    Product Code
    FRN
    PMA / PMN Number
    K873961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A HOUSEHOLD PET CHEWED THROUGH THE TUBE SET DURING TREATMENT. NO ONE WAS EXPOSED TO MEDICATION. LINE WAS TIED INTO A KNOT AND PUMP TURNED OFF. COMPLAINANT RETURNED PUMP TO THE USER FACILITY AND WAS GIVEN A NEW ONE. PATIENT COULD NOT PROVIDE THE MODEL, LOT NUMBER, OR SERIAL NUMBER OF THE PUMP NOR THE TUBE SET. COMPLAINANT WAS CONFIDENT HE NOR HIS WIFE WERE EXPOSED. THEY WASHED THEIR HANDS TO BE SAFE. NO INJURY REPORTED. NO EVIDENCE OF DEVICE MALFUNCTION. THE EVENT WAS CAUSED BY A DOG CHEWING THROUGH THE TUBE SET DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237702 WALKMED INFUSION PUMP FRN WALKMED INFUSION, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other