BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALIST(R) STERILE COTTON BLEND STERILE CAST PADDING

    MDR report key: 21911764 · Received April 25, 2025

    Report

    Report Number
    MW5169527
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 18, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BSN MEDICAL, INC.
    Product Code
    ITG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PROVIDER HAD SIGNIFICANT ISSUES WITH THE STERILE 4X4 HONEYCOMB SPECIALIST COTTON BLEND CAST PADDING REF # 72345-02. THE HONEYCOMB PADDING WAS DISINTEGRATING WHEN BEING APPLIED TO THE KNEE. THIS IS THE CAST PADDING SIZE 6" STERILE CAST PADDING. PROVIDER STATES "IT DISINTEGRATES" AND IS "NOT ACCEPTABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428357 SPECIALIST(R) STERILE COTTON BLEND STERILE CAST PADDING BANDAGE, CAST ITG BSN MEDICAL, INC. 72345-02 318326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown