BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ MEDIPORE¿ H SOFT CLOTH SURGICAL TAPE

    MDR report key: 23067480 · Received September 16, 2025

    Report

    Report Number
    2110898-2025-00058
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    July 13, 2025
    Report Date
    September 16, 2025
    Manufacturer
    3M COMPANY
    Product Code
    KGX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED AND A SAMPLE IS NOT AVAILABLE. THIS COMPLAINT WAS LOCATED ON THE FDA MAUDE DATABASE, AND REPORTER INFORMATION WAS NOT DISCLOSED. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    PER REVIEW OF REPORT: MW5172957 ON THE MAUDE DATABASE: A PATIENT NOTIFIED THE CLINIC THAT THEY HAD AN ALLERGY TO ADHESIVE, AND THE AMBULATORY SURGERY CENTER (ASC) STAFF APPLIED 3M¿ MEDIPORE¿ H SOFT CLOTH SURGICAL TAPE ON THE PATIENT TO SECURE LEAD WIRES IN ADDITION TO 3M¿ STERI-STRIP¿ REINFORCED ADHESIVE SKIN CLOSURES AND 3M¿ TEGADERM¿ TRANSPARENT FILM DRESSING. THE PATIENT CONTACTED THE PROVIDER AND INFORMED OF ITCHINESS. THE PROVIDER'S OFFICE HAD THE PATIENT VISIT TO RE-DRESS THE INJECTION SITES. THE PATIENT STARTED TAKING ALLEGRA® AND BENADRYL®. TWO DAYS LATER, THE PATIENT CONTACTED A MANUFACTURER REPRESENTATIVE THAT THEY WERE HAVING HIVES AND THE PROVIDER SENT HYDROXYZINE TO PHARMACY. THE PROVIDER THEN DECIDED TO HAVE PATIENT VISIT THE SAME DAY TO REMOVE EVERYTHING AND STOPPED THE SPINAL CORD STIMULATION TRIAL PROCEDURE EARLY. ISSUE REGARDING 3M¿ STERI-STRIP¿ REINFORCED ADHESIVE SKIN CLOSURES IS INVESTIGATED UNDER MDR 2110898-2025-00057. ISSUE REGARDING 3M¿ TEGADERM¿ TRANSPARENT FILM DRESSING IS INVESTIGATED UNDER MDR 2110898-2025-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681105 3M¿ MEDIPORE¿ H SOFT CLOTH SURGICAL TAPE TAPE AND BANDAGE, ADHESIVE KGX 3M COMPANY 2861 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention