BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPP 10% POVIDONE IODINE APPLICATOR

    MDR report key: 27734 · Received November 1, 1995

    Report

    Report Number
    MW1007534
    Event Type
    Other
    Date Received
    November 1, 1995
    Date of Event
    October 31, 1995
    Report Date
    November 1, 1995
    Manufacturer
    MEDI-FLEX
    Product Code
    EFQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN AMPULE WAS BROKEN, A SLIVER OF GLASS PENETRATED THE OUTER PLASTIC SLEEVE AND CUT THE EMPLOYEE'S HAND WHILE BLOOD CULTURES WERE BEING DONE. THERE DID NOT APPEAR TO BE ANY BLOOD-TO-BLOOD CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPP 10% POVIDONE IODINE APPLICATOR APPLICATOR EFQ MEDI-FLEX 503032

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other