BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESIO CATHETER

    MDR report key: 38540 · Received September 17, 1996

    Report

    Report Number
    MW1009937
    Event Type
    Injury
    Date Received
    September 17, 1996
    Date of Event
    May 28, 1996
    Report Date
    September 9, 1996
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED RETRO PERITONEAL HEMORRHAGE FOLLOWING PLACEMENT OF A SUBCLAVIAN TRANSLUMBAR INTRACAVAL CATHETER. NO OTHER ALTERNATIVE VASCULAR ACCESS FOR HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESIO CATHETER SUBCLAVIAN CATHETER FOR DIALYSIS LFJ MEDICAL COMPONENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization