BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI STRIPS

    MDR report key: 23165487 · Received September 29, 2025

    Report

    Report Number
    MW5176646
    Event Type
    Injury
    Date Received
    September 29, 2025
    Report Date
    September 22, 2025
    Manufacturer
    3M / SOLVENTUM US LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A (B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: PATIENT (PT) REPORTED THEY WERE ALLERGIC TO THE STERI-STRIPS OVER THEIR IMPLANT SITE SO THE AREA "BLEW UP". PATIENT SAID AS TIME HAS GONE THE STERI-STRIPS HAVE FALLEN OFF AND, ON THE SITUATION, HAS GOTTEN MUCH BETTER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218723 STERI STRIPS TAPE AND BANDAGE, ADHESIVE KGX 3M / SOLVENTUM US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown