BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10452779 · Received August 26, 2020

    Report

    Report Number
    3005483737-2020-00011
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Report Date
    August 26, 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

    SINCE THE ACTUAL SAMPLE WAS EVALUATED AT OUR GROUP COMPANY DEGANIA SILICONE LTD., (B)(4) THERE IS NO ANY VISIBLE DEFECTS ON THE BALLOON. SINCE THE BATCH WAS TESTED 100% BY INFLATION AND DEFLATION OF THE BALLOON WITH AIR AND PASSED 100% VISUAL INSPECTION OF INFLATED BALLOONS AND DID NOT DETECT ANY NON CONFORMITIES AND THE RETAINED SAMPLES FROM THIS BATCH S16038505 TESTED AND WAS FOUND OK SO, THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED. 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 MDR REPORT # 8030107-2020-00024 FILED BY DEGANIA SILICONE LTD.)

    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, ON (B)(6) 2017, PRE-OPERATIVELY, THE BALLOON OF THE PROBE OF THE FOLEY CATHETER WITH TEMP IS POROUS. NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918087 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 S16038505

    Patients

    Seq Age Sex Outcome Treatment
    1