BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO AVF SET

    MDR report key: 91331 · Received May 15, 1997

    Report

    Report Number
    1118880-1997-00104
    Event Type
    Injury
    Date Received
    May 15, 1997
    Report Date
    April 17, 1997
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLEEDING AT ACCESS SITE. EXCESSIVE BLEEDING AT END OF TREATMENT, AND 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. NA VC2451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention