BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M¿ STERI-STRIP¿

    MDR report key: 19749001 · Received July 16, 2024

    Report

    Report Number
    19749001
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 24, 2024
    Manufacturer
    3M COMPANY
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN OPENING 1" STERI-STRIP, IT WAS DISCOVERED THAT THERE WAS A SEAL MISSING ON THE LEFT SIDE OF THE PACKAGE CAUSING PRODUCT TO BE NOT STERILE. ALL AFFECTED PRODUCTS THAT WERE NOT SEALED PROPERLY WERE TAKEN OFF THE SHELF AND GIVEN TO LOGISTICS. ALL STERI-STRIP 1" AND 1/2" WERE LOOKED AT AND ALL PRODUCTS THAT WERE SEALED CORRECTLY WERE LEFT ON THE SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523648 3M¿ STERI-STRIP¿ TAPE AND BANDAGE, ADHESIVE KGX 3M COMPANY R1548 33K5XF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown