BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV SCIG 26G 9MM FLO

    MDR report key: 8739952 · Received June 26, 2019

    Report

    Report Number
    MW5087662
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 10, 2019
    Manufacturer
    REPRO-MED SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REPORTED SHE HAD LEAKING AT THE END OF ONLY ONE HIZENTRA INFUSION ON (B)(6) 2019 BUT WAS ABLE TO FINISH THE INFUSION, AND REPORTED REDNESS THAT WAS PROBABLY CAUSED BY BANDAID ADHESIVE. WE HAVE SHIPPED DIFFERENT TUBING AND BANDAIDS TO PT. NO OTHER INFO KNOWN. REPORTED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531561 IV SCIG 26G 9MM FLO SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC.
    531589 BANDAID ADHESIVE TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR