BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER

    MDR report key: 10709508 · Received October 21, 2020

    Report

    Report Number
    3005483737-2020-00022
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 5, 2018
    Report Date
    October 21, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT IS FILED RETROSPECTIVELY FOLLOWING FDA OBSERVATION NUMBER 4 RECEIVED BY DEGANIA MEDICAL DEVICES PVT. LTD. DURING THE FDA INSPECTION OF 4-7 OF NOVEMBER 2019. THE OBSERVATION WAS RELATED TO THE FACT THAT DEGANIA MEDICAL DEVICES PVT. LTD. DID NOT ESTABLISH PROCEDURES FOR REPORTING MDRS TO FDA AS A MANUFACTURER. TILL THEN ALL COMPLAINTS RELATED TO THE DEVICES PRODUCED BY DMD WERE ASSESSED FOR MDR REPORTABILITY AND SUBMITTED AS NECESSARY TO FDA BY DEGANIA SILICONE LTD. ANOTHER Q MEDICAL DEVICES DIVISION CLOSELY AFFILIATED WITH DMD. DMD CAPA NUMBER (B)(4) WAS ISSUED TO ADDRESS THE OBSERVATION; ONE OF THE CAPA ACTIONS REQUIRES DMD TO PERFORM RETROSPECTIVE REVIEW OF ALL THE COMPLAINTS RECEIVED DURING 2018 AND 2019 AND SUBMIT TO FDA RETROSPECTIVE MDRS FOR THE REPORTABLE EVENTS (WITH REFERENCE TO ORIGINAL REPORTED TO FDA REPORT # 8030107-2019-00020 FILED BY DEGANIA SILICONE LTD.) IN SUMMARY, UNTIL THE CATHETER IS CHECKED, IT IS NOT POSSIBLE TO CONCLUDE THAT THE CATHETER HAD ANY MALFUNCTION. WE CLOSE THIS COMPLAINT AS NOT JUSTIFIED.

    Description of Event or Problem · 1

    THIS IS RETROSPECTIVE SUBMISSION, FOLLOWING REASSESSMENT OF OUR CUSTOMER COMPLAINTS DURING PERIOD 2018-2019. CUSTOMER'S TEXT: ACCORDING TO THE REPORTER, IT WAS REPORTED THAT A (B)(6) YO, MALE PATIENT, WEIGHING (B)(6)KG ADMITTED FOR BURN OVER 40% OF THE BODY, CURRENTLY UNSTABLE CONDITION, IN THE ICU BEING TREATED FOR BURNS, RESPIRATORY ASSISTANCE, AND SEPSIS. URINARY CATHETER INSERTED ON (B)(6) 2018, AND (B)(6) 2018, AND PATIENT BECAME VERY UNSTABLE, TEMPERATURE MONITORING FROM FOLEY MEASURED 37.6 DEGREE CENTIGRADE WHILE ESOPHAGEAL MEASUREMENT SHOWED 41.1 DEGREE CENTIGRADE. PATIENT WAS CALLED DOWN VIA MULTIPLE METHODS. DUE TO EDEMA OF GENITALS IT IS NOT POSSIBLE TO REMOVE CATHETER AT THIS TIME, BUT CUSTOMER REPORTED ONCE THEY ARE ABLE TO REMOVE IT, PRODUCT WILL BE SENT FOR FAILURE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180471 MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 14 FRENCH S18005350

    Patients

    Seq Age Sex Outcome Treatment
    1