BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP GLOBAL

    MDR report key: 9863352 · Received March 21, 2020

    Report

    Report Number
    3014527682-2020-00005
    Event Type
    Malfunction
    Date Received
    March 21, 2020
    Date of Event
    March 13, 2020
    Report Date
    March 21, 2020
    Manufacturer
    ASP GLOBAL
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    BLUE FIBERS CAME OFF COTTON TOWEL AND WENT INTO WOUND FROM REGARD CUSTOM PACK 880119, LOT 1925636745. INCIDENT WAS DISCOVERED DURING PROCEDURE. THE DOCTOR HAD TO PICK BLUE FIBERS OUT OF WOUND. PATIENT HARM IS CURRENTLY UNABLE TO BE DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327089 ASP GLOBAL O.R. TOWEL COTTON BLUE FRL ASP GLOBAL ORT400 Q1110LK

    Patients

    Seq Age Sex Outcome Treatment
    1