BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER UROLOGICAL

    MDR report key: 10464195 · Received August 28, 2020

    Report

    Report Number
    3005483737-2020-00013
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    March 5, 2019
    Report Date
    August 28, 2020
    Manufacturer
    DEGANIA MEDICAL DEVICES PVT. LTD
    Product Code
    KOD
    PMA / PMN Number
    K860484
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE ACTUAL SAMPLE WAS NOT AVAILABLE AND THE BATCH REVIEW OF THE POSSIBLE LOT NUMBERS V1456043 AND V15000097 HAS BEEN DONE NO NONCONFORMITIES WERE REPORTED DURING PRODUCTION AND 100% BALLOON TESTING. WE DID NOT DETECT ANY NONCONFORMITY DURING THE BATCH REVIEW OF POSSIBLE LOT NUMBERS DURING BATCH REVIEW AND VISUAL INSPECTION OF RETAIN SAMPLES OF THESE TWO LOTS. WE CONSIDER THIS COMPLAINT 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 # 8030107-2020-00027 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, THE BALLOON IS BROKEN. THERE WAS NO HARM TO THE PATIENT . NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929556 CATHETER UROLOGICAL FOLEY CATHETER KOD DEGANIA MEDICAL DEVICES PVT. LTD 08 FRENCH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1