BEUDAMED
    FDA Adverse Event Injury Summary report: N

    61301 STER GZE PADS 100'S 2X2

    MDR report key: 10360007 · Received August 3, 2020

    Report

    Report Number
    1018120-2020-00419
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    June 19, 2020
    Report Date
    October 6, 2020
    Manufacturer
    COVIDIEN
    Product Code
    NAB
    UDI-DI
    30884521083947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 HAS BEEN UPDATED TO INCLUDE THE NAME AND ADDRESS OF THE DISTRIBUTOR WHO REPORTED THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPOUSE OF A HOME PATIENT CONTACTED BAXTER BY PHONE AND REPORTED THAT THE PATIENT GOT AN INFECTION ON TUBE SITE AND THE SWABSTICKS (BAXTER PRODUCT CODE EK4061, LOT # UNKNOWN, (B)(4)) WERE MAKING IT IRRITATED AND INFLAMED. THE SKIN GOT SUPER RED AND IT BURNED AND HURT EVERY TIME THEY APPLIED IT. THEY GOT A SET OF IODINE SWABS FROM THE CLINIC THAT THEY ARE USING FOR NOW AND IT DOES NOT IRRITATE THE WOUND. THE PATIENT ALSO USED GAUZE, 2X2 STERILE (PRODUCT CODE EK7417, LOT # UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824361 61301 STER GZE PADS 100'S 2X2 GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE NAB COVIDIEN 61301 30884521083947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other