BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALIST®

    MDR report key: 16673521 · Received April 4, 2023

    Report

    Report Number
    16673521
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 14, 2023
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    ITG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SO IT LOOKS LIKE SOME OF THE 6 INCH X 4 YDS SPECIALIST COTTON BLEND STERILE CAST PADDING (ITEM 76041608) HAS BEEN COMING IN WITH SOME OF THEM NOT FULLY SEALED. I FOUND TWO THAT WERE LIKE THAT AND JUST WANTED TO ASK IF THERE WAS SOMETHING THAT I NEEDED TO DO ABOUT THAT? THE LOT NUMBER THAT THEY CAME FROM IS 303188. WILL REPORT TO BSN - SECOND REPORT ON SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900896 SPECIALIST® BANDAGE, CAST ITG BSN MEDICAL INC. 72345-03 303188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown