BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOWEL OR BLUE 17X25IN N ST

    MDR report key: 12901392 · Received November 30, 2021

    Report

    Report Number
    3014527682-2021-00021
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 30, 2021
    Manufacturer
    A PLUS INTERNATIONAL
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BLUE OR TOWEL WAS CONTAINED INSIDE A CUSTOM PROCEDURE KIT MANUFACTURED BY ROI CPS, LLC. ROI CPS, LLC IS NOT THE MANUFACTURER OF THE TOWELS THAT WERE FOUND TO BE LINTING BY THE END USER.

    Description of Event or Problem · 0

    THERE WAS LINT ON THE BLUE TOWELS IN CUSTOM PACK. LINT WAS FOUND ON TOWELS AND WIRES USED DURING THE PROCEDURE. THERE WAS PATIENT CONTACT, BUT NO HARM TO PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800148 TOWEL OR BLUE 17X25IN N ST FRL A PLUS INTERNATIONAL OR-1725-BS F94699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown