BEUDAMED
    FDA Adverse Event Other Summary report: N

    81-020409 GENERAL PURPOSE PROBE YSI400

    MDR report key: 452546 · Received April 4, 2003

    Report

    Report Number
    1046367-2003-00001
    Event Type
    Other
    Date Received
    April 4, 2003
    Report Date
    March 5, 2003
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FLL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROBE IS TOO RIGID AND INFLEXIBLE FOR RECTAL INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 81-020409 GENERAL PURPOSE PROBE YSI400 NASAL/RECTAL PROBES FLL DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other