BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER WITH TEMPERATURE SENSOR

    MDR report key: 10204455 · Received June 28, 2020

    Report

    Report Number
    3005483737-2020-00004
    Event Type
    Malfunction
    Date Received
    June 28, 2020
    Date of Event
    May 6, 2020
    Report Date
    June 2, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT "WE WERE NOT ABLE TO EXTRACT FLUID OUT OF THE BALLOON. WE CHECKED THE BATCH HISTORY RECORDS AND NO NON CONFORMITIES WERE DETECTED. THE RETAIN SAMPLES FROM THE SAME BATCH WAS TESTED AND IT FUNCTIONED PROPERLY, THE INFLATION AND DEFLATION TEST OF BALLOON WAS FOUND OK. WE RECEIVED THE COMPLAINT SAMPLE, TESTED AND DID NOT DETECT ANY NON CONFORMITY, THE CATHETER FUNCTIONED PROPERLY. SO, THE COMPLAINT IS NOT JUSTIFIED.

    Description of Event or Problem · 1

    WE WERE NOT ABLE TO EXTRACT FLUID OUT OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668428 FOLEY CATHETER WITH TEMPERATURE SENSOR TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 08 FRENCH S19002131

    Patients

    Seq Age Sex Outcome Treatment
    1