BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED, LLC

    MDR report key: 12916552 · Received December 2, 2021

    Report

    Report Number
    3000204189-2021-00001
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 1, 2021
    Manufacturer
    WALKMED, LLC
    Product Code
    FPA
    PMA / PMN Number
    K870524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CLINIC REPORTED "THE BAGS HAVE PARTICLES WITHIN THE BAGS UPON OPENING". THERE WAS NO PATIENT IMPACT SINCE THE PARTICULATE WAS IDENTIFIED DURING SETUP. THE RESERVOIR BAG IS IN TRANSIT TO BE RETURNED TO WALKMED. PICTURE WAS REVIEWED AND COULD NOT BE VERIFIED WHETHER THE PARTICULATE WAS LOOSE INSIDE THE BAG OR EMBEDDED IN THE WALL. WALKMED REVIEWED RETAINED SAMPLES FROM THE SAME LOT AND DID NOT WITNESS ANY PARTICULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819601 WALKMED, LLC RESERVOIR BAG FPA WALKMED, LLC 21020525

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other