BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16-5301-0, MICROPORE-SURGICAL TAPE 1X10YDS

    MDR report key: 24481438 · Received March 2, 2026

    Report

    Report Number
    MW5184549
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    December 9, 2025
    Report Date
    February 26, 2026
    Manufacturer
    SOLVENTUM US LLC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT CALLED IN TO MAKE SURE HER ORDER WAS IN. WHILE CONVERSING WITH THE PATIENT, SHE STATED THAT THE PAPER TAPE SHE USED, "HER SKIN DID NOT LIKE IT." WHEN I ASKED HER TO CLARIFY WHAT SHE MEANT. THE PATIENT STATED THAT IT MADE HER ITCH ALL OVER THE PLACE, AND SHE COULD NOT WAIT TO TAKE IT OFF. LOOKING INTO HER NEW PATIENT ORDER, SHE RECEIVED 16-5301-0 SURGICAL TAPE ON NEW PATIENT DELIVERY. SURGICAL TAPE IS NOT ON THE PATIENT'S PRESCRIPTION. PAPER TAPE IS. THE PATIENT STATED THAT THE SILK TAPE SHE RECEIVED ON HER NEW PATIENT DELIVERY HAS NOT CAUSED HER TO ITCH AT ALL. WILL CREATE RGA FOR SURGICAL TAPE. NO NEW ORDER NEEDED AS THE PATIENT WILL CONTINUE TO USE THE SILK TAPE FROM HER NEW PATIENT DELIVERY ON (B)(6) 2026. A TECH SUPPORT SPECIALIST CLARIFIED THAT "THE SURGICAL TAPE THAT WAS SENT TO HER ON HER INITIAL NEW PATIENT DELIVERY CAUSED HER SKIN TO ITCH. CLINIC CHANGED TAPE TO PAPER TAPE FROM SURGICAL TAPE. SHE ALSO CONFIRMED THE (16-5301-0, MICROPORE-SURGICAL TAPE 1X10YDS) TAPE IS THE PRODUCT THAT CAUSED THE REACTION". "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
    553603 16-5301-0, MICROPORE-SURGICAL TAPE 1X10YDS TAPE AND BANDAGE, ADHESIVE KGX SOLVENTUM US LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown