BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER - CONVERTORS

    MDR report key: 117747 · Received September 4, 1997

    Report

    Report Number
    117747
    Event Type
    Malfunction
    Date Received
    September 4, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 13, 1997
    Manufacturer
    BAXTER - CONVERTORS/HOSPITAL SUPPLY DIVISION
    Product Code
    FYF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MRI SHOWED METAL ARTIFACT PT QUESTIONED, DENYED ANY METAL, BB, ETC. WHEN FINISHED BROKEN SEWING MACHINE NEEDLE FOUND WOVEN IN "COMFORT BOUFFANT CAP" ELASTIC BAND. SIGNIFICANT HAZARD POTENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER - CONVERTORS COMFORT BOUFFANT CAP FYF BAXTER - CONVERTORS/HOSPITAL SUPPLY DIVISION * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other