BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO AVF SET

    MDR report key: 81647 · Received April 4, 1997

    Report

    Report Number
    1118880-1997-00077
    Event Type
    Injury
    Date Received
    April 4, 1997
    Report Date
    March 5, 1997
    Manufacturer
    TERUMO MEDICAL CORP (MD) EAST
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE WAS DULL. LEAKAGE AT INSERTION SITE. GELFOAM WAS USED TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP (MD) EAST NA UM0151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention