BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING AND TANDEM COMBINATION APPLICATOR SET

    MDR report key: 2516733 · Received March 30, 2012

    Report

    Report Number
    9612638-2012-00003
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 6, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K952913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFO PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFO CURRENTLY AVAILABLE IS TRUE AND ACCURATE. A FOLLOW UP OF THIS MDR IS EXPECTED AND WILL BE SUBMITTED AS SOON AS THE PART IS RECEIVED AND INVESTIGATED.

    Description of Event or Problem · 1

    CUSTOMER HAS NOTICED THAT ON FIRST USE OF THE RECTAL RETRACTOR ((B)(4)), PART OF THE RING AND TANDEM COMBINATION APPLICATOR SET ((B)(4)), BLOOD SEEPED BETWEEN THE SMALL RIVETS HOLDING THE PADDLE IN PLACE ALONG THE METAL FIXATION STEM. THE PROBLEM WAS NOTICED AFTER CLINICAL USE BUT CUSTOMER CONFIRMED THAT THERE WAS NO CROSS CONTAMINATION OR PT INJURY. THE AFFECTED PART WAS SEPARATED TO PREVENT FROM FURTHER CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RING AND TANDEM COMBINATION APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other