BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPE HY-TAPE 1"X5YD

    MDR report key: 15864819 · Received November 23, 2022

    Report

    Report Number
    MW5113462
    Event Type
    Injury
    Date Received
    November 23, 2022
    Report Date
    November 18, 2022
    Manufacturer
    HY-TAPE INTERNATIONAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING INBOUND CALL FOR CONSULT ON PATIENT'S SQ TREPROSTINIL, PATIENT REPORTED: DATE OF LAST SITE CHANGE: (B)(6) 2022. REPORTS SITE PAIN AND ITCH AT THIS TIME AS WELL AS IRRITATION. PT BELIEVES IT MAY BE THE HYTAPE COULD BE CAUSING THIS. PT IS SEEING MD IN PERSON TO DISCUSS NEXT WEEK (WEDNESDAY). PT ALSO REPORTED THAT SHE FELT IT WAS HARDER TO BREATHE WHEN SHE IS WALKING OUTSIDE NOW. SHE HAS OXYGEN AVAILABLE FOR USE AND HAS NOT HAD TO INCREASE HER OXYGEN AT THIS TIME. SHE IS INFORMING MD AT HER VISIT NEXT WEEK. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797776 TAPE HY-TAPE 1"X5YD TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female