BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARD-AL-I-6-100-WB-PERFORMA

    MDR report key: 223018 · Received May 11, 1999

    Report

    Report Number
    1628221-1999-00038
    Event Type
    Injury
    Date Received
    May 11, 1999
    Date of Event
    May 1, 1999
    Report Date
    May 5, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP 05/14/1999: THE CLIENT STATES THAT THIS WAS A DIFFICULT CASE. SEVERAL CATHETERS HAD ALREADY BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARD-AL-I-6-100-WB-PERFORMA DIAGNOSTIC INTRAVASCULAR CATHETER DQO MALLINCKRODT MEDICAL, INC. NA M387410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R HEXABRIX 350 CONTRAST MEDIUM.| BARD INTRODUCER, 0.035" TEFLON GUIDEWIRE, AND