BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT/MR TANDEM APPLICATOR

    MDR report key: 2422823 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00014
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    October 15, 2009
    Report Date
    December 23, 2011
    Manufacturer
    NUCLETRON, BV
    Product Code
    JAQ
    PMA / PMN Number
    K983341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED OCTOBER 28, 2011, NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    DURING INSERTION OF THE TANDEM, THE 60MM 30 DEGREE IU TUBE SNAPPED ON THE WHITE INTRO-UTERINE PART. NO EXTRA FORCE WAS APPLIED DURING THIS INSERTION COMPARED TO PREVIOUS ONES. THE APPLICATOR HAD TO BE REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT/MR TANDEM APPLICATOR VAGINAL CT/MR APPLICATOR SET JAQ NUCLETRON, BV 101053 003869

    Patients

    Seq Age Sex Outcome Treatment
    1 NA