BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFER GUIDE TUBE

    MDR report key: 1753889 · Received July 8, 2010

    Report

    Report Number
    1124791-2010-00004
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    May 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    JAQ
    PMA / PMN Number
    K061582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVENT (B)(4) WAS REPORTED TO VARIAN MEDICAL SYSTEMS, INC FROM THE (B)(6) INVESTIGATOR. THE USER SITE HAD NOT PREVIOUSLY REPORTED THE EVENT TO VARIAN.

    Description of Event or Problem · 1

    BRACHYTHERAPY PT DEVELOPED RADIATION SKIN REACTION AFTER BEING TREATED WITH A VAGINAL CYLINDER APPLICATOR FOR THREE FRACTIONS. NO ABNORMAL ISSUES NOTICED AT TIME OF ANY OF THE THREE TREATMENTS ALTHOUGH A PHYSICIAN MAY HAVE HAD A MORE DIFFICULT TIME GETTING THEIR HANDS ON THE APPLICATOR TO FASTEN THE TRANSFER GUIDE TUBE (TGT). PT CALLED HER PHYSICIAN SOME NUMBER OF DAYS FOLLOWING COMPLETION OF TREATMENT TO REPORT SKIN IRRITATION ON UPPER THIGHS. A PHYSICIST AT LOVELACE INFORMED VARIAN MEDICAL SYSTEMS THAT THE BEST ESTIMATE FOR SKIN DOSE TO THE PT WAS "IN THE THOUSANDS OF RAD", AND THAT THE DOSE AT 2CM WAS APPROXIMATELY 700 RAD. HIS CALCULATIONS WERE BASED ON HIS BEST GUESS OF WHAT HAPPENED AND ASSUMED A GAP OF 7MM BETWEEN THE SOURCE AND THE PT. A BLANKET WAS ALSO BETWEEN THE SOURCE AND PT. THE AREA INVOLVED ON THE PT'S THIGH DEVELOPED MOIST DESQUAMATION. THE AREA IS HEALING AND IS NOW RED AND FLAKY. THE PT IS (B)(6), VERY HEAVY AND HAS SHORT TERM MEMORY PROBLEMS. THEY ARE NOT CERTAIN OF WHICH FRACTION THE ERROR OCCURRED ON, BUT BELIEVE IT WAS THE THIRD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSFER GUIDE TUBE BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC AL07292001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other VARISOURCE AFTERLOADER: VS00220| MICK NUCLEAR RADIO INSTRUMENTS VAGINAL CYLINDER:| (B)(4)| MODEL# 9805,