BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH SHEATH

    MDR report key: 34522 · Received July 17, 1996

    Report

    Report Number
    34522
    Event Type
    Injury
    Date Received
    July 17, 1996
    Date of Event
    June 25, 1996
    Report Date
    July 11, 1996
    Manufacturer
    MEDITECH, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF AN ARTERIAL SHEATH IN THE LEFT GROIN CAUSED THE PT TO HEMORRHAGE. UPON REMOVAL OF THE SHEATH IT WAS DISCOVERED THAT THE SHEATH HAD SEPARATED INTO TWO PIECES. THE SECOND PIECE WAS REMOVED WITHOUT INCIDENT. THE PT WAS DISCHARGED THE FOLLOWING MORNING WITH NO RESIDUAL PROBLEMS OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH SHEATH Implant ARTERIAL SHEATH DYB MEDITECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention