BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 10709883 · Received October 21, 2020

    Report

    Report Number
    3005483737-2020-00023
    Event Type
    Death
    Date Received
    October 21, 2020
    Date of Event
    August 8, 2018
    Report Date
    October 21, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    EZL
    PMA / PMN Number
    K063442
    Adverse Event
    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 73/19 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. THE EVENT WAS REPORTED TO FDA BY DSL WITH THE REPORT #8030107-2018-003. IN SUMMARY, THERE WAS LACK OF CLARITY WHETHER THE INACCURATE TEMPERTURE MEASUREMENT WAS DUE TO A DEVICE MALFUNCTION OR DUE TO AN INHERENT LIMITATION OF URINARY TEMPERATURE MEASUREMENT WHEN URINE OUTPUT IS LOW. EITHER WAY, THE MEDICAL IMPLICATION OF DELAYED FEVER REDUCTION IN FEBRILE INFECTED ICU-PATIENTS IS UNCLEAR. THE CURRENT DATA DO NOT SUPPORT INTENSIVE ACTIVE FEVER REDUCTION IN THESE PATIENTS TO IMPROVE MORTALITY. THERE IS NO CLEAR LINK BETWEEN THE INACCURATE TEMPERATURE READING TO THE PATIENT DEATH 3 DAYS LATER. ATTACHED THE UPDATED CLINICAL COMMENTARY FROM THE MEDICAL CONSULTANT DATED (B)(6) 2018.

    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, POST -OPERATIVELY, THE DEVICE MEASURED WRONG TEMPERATURE WHILE IT WAS USED ON PATIENT. IT WAS REPORTED THAT THE PATIENT WAS SWEATING BUT THE DEVICE SHOWED A TEMPERATURE OF 34 DEGREE CELSIUS. IT WAS STATED THAT A SPOT CHECK MEASUREMENT AT THE EAR WAS DONE AND SHOWED 41.4 DEGREE CELSIUS. THE CUSTOMER REPORTED THAT THERE WAS A PATIENT DEATH AND CAUSE WAS ASKED BUT UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176886 MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 16 FRENCH S18005977

    Patients

    Seq Age Sex Outcome Treatment
    1