BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 10776286 · Received November 3, 2020

    Report

    Report Number
    3005483737-2020-00026
    Event Type
    Death
    Date Received
    November 3, 2020
    Date of Event
    October 16, 2018
    Report Date
    November 2, 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 8030107-2019-00021 REPORT FILED BY DEGANIA SILICONE LTD.) THE CUSTOMER INDICATED THAT THE CATHETER BROKE FOLLOWING "WORRYING MOVEMENT PATTERNS" OF THE PATIENT WHO IS IN PALLIATIVE STATE. THE BREAKAGE DID NOT HAPPEN FOLLOWING ABY MANUFACTURING FAILURE; THEREFORE NO CORRECTIVE ACTION IS REQUIRED IN THIS CASE.

    Description of Event or Problem · 1

    THIS IS RETROSPECTIVE SUBMISSION, FOLLOWING RE-ASSESSMENT OF OUR CUSTOMER COMPLAINTS DURING PERIOD 2018-2019. CUSTOMER'S TEXT: ACCORDING TO THE REPORTER, DURING A NORMAL USE, THE PATIENT HAD WORRYING MOVEMENT PATTERNS, WHICH MOVED THE CATHETER, AND BROKE. IT WAS REPORTED THAT 10 TO 15 CM OF THE CATHETER WAS STILL IN THE URETHRA OR BLADDER. THE PATIENT WAS IN A PALLIATIVE STATE, AND IT IS DEEMED NOT APPROPRIATE FOR FURTHER ACTION. ON 29/11/18 THE CUSTOMER UPDATED US THAT THE PATIENT HAS DIED. THE CATHETER BREAKAGE WAS CONFIRMED TO BE CAUSED BY PATIENT'S CONDITION, AND THE DEATH WAS CONFIRMED NOT TO BE RELATED TO THE DEVICE OF DEGANIA (THE PATIENT WAS AT TERMINAL STATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242588 MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER EZL DEGANIA MEDICAL DEVICES PVT. LTD 12 FRENCH S18006674

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization