BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POURCHEZ RETRO

    MDR report key: 474931 · Received July 30, 2003

    Report

    Report Number
    1223643-2003-00002
    Event Type
    Injury
    Date Received
    July 30, 2003
    Report Date
    July 30, 2003
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CATHETER PULLED OUT OF THE PATIENT. CATHETER HAD TO BE REPLACED. PHYSICAL CONDITION OF THE PATIENT WAS AN ISSUE DUE TO THEIR LARGE BREASTS. THIS WAS THE SECOND OCCURRENCE WITH THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POURCHEZ RETRO CHRONIC HEMODIALYSIS CATHETER MSD SPIRE BIOMEDICAL, INC. RM27SH32 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention