BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOSEAL

    MDR report key: 307704 · Received December 8, 2000

    Report

    Report Number
    307704
    Event Type
    Other
    Date Received
    December 8, 2000
    Date of Event
    November 28, 2000
    Report Date
    December 6, 2000
    Manufacturer
    ANGIOSEAL, ST JUDE MEDICAL/DIAG DIV
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD ANGIO SEAL FOR VASCULAR CLOSURE OF CATH. READMITTED WITH INFECTION AT SAME SITE. CULTURES WERE POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR CLOSURE DEVICE MGB ANGIOSEAL, ST JUDE MEDICAL/DIAG DIV UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other