BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-DG HEALTH,BANDAGE,STRONG STRIP,60CT

    MDR report key: 12322239 · Received August 14, 2021

    Report

    Report Number
    1417592-2021-00152
    Event Type
    Malfunction
    Date Received
    August 14, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 18, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL MDR FILED ON 8/18/2021 TO REFLECT CORRECTED/CHANGE MADE IN D2, PRODUCT CODE CHANGED FROM FRO TO KGX PER DIVISION QA M.S. 8/18/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED, "BANDAGES ARE CAUSING SORES." REPORTED MEDICAL INTERVENTION SOUGHT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "BANDAGES ARE CAUSING SORES." REPORTED MEDICAL INTERVENTION SOUGHT. IT WAS REPORTED, "BANDAGES ARE CAUSING SORES." REPLY EMAIL RECEIVED BY END USER MARQUE BLUBAUGH ON 8/9/2021 THAT STATES, "STILL GETTING TREATED. WHEN I FEEL BETTER, I WILL REPLY. CANT RIGHT NOW. JUST WENT TO WOUND CENTER." END USER STATES, "I WILL PRESENT AS SOON AS INFORMATION IS CONFORMED AND AVAILABLE." DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. IT IS UNKNOWN IF SAMPLES ARE AVAILABLE FOR RETURN AND EVALUATION. THEREFORE, A TRUE ROOT CAUSE WILL BE DIFFICULT TO DETERMINE. DUE TO THE REPORTED INCIDENT, REPORTED MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MED WATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MED WATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "BANDAGES ARE CAUSING SORES." REPORTED MEDICAL INTERVENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219485 DBD-DG HEALTH,BANDAGE,STRONG STRIP,60CT KGX MEDLINE INDUSTRIES INC. 90920060001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention