BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1654916 · Received April 6, 2010

    Report

    Report Number
    2916710-2010-00031
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    May 9, 2005
    Report Date
    March 9, 2010
    Product Code
    IYE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT DID NOT IDENTIFY A VARIAN DEVICE NAME AND/OR MODEL NUMBER. FURTHER INVESTIGATION DETERMINED THAT THE TREATMENT CENTER IS EQUIPPED WITH VARIAN PRODUCT. HOWEVER, WE HAVE NO REPORT OF A PRODUCT MALFUNCTION ON FILE DURING THE TIME FRAME MENTIONED IN THE PATIENT'S REPORT. VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE BASED ON THE PATIENT'S ALLEGATION OF RADIATION BURNS. (B) (4).

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS RECEIVED A LETTER FROM A PATIENT THAT RECEIVED RADIATION TREATMENT TO THE HEAD AND NECK IN (B) (6), FROM (B) (6) 2005 TO (B) (6) 2005. THE PATIENT WAS BEING TREATED FOR SQUAMOUS CELL CARCINOMA OF THE TONGUE. THE LETTER ALLEGES THE PATIENT RECEIVED 6,600 CGY IN 33 FRACTIONS TO THE ORAL TONGUE WITH 4,600 CGY TO THE CERVICAL AND SUPRACLAVICULAR LYMPH NODES. IN 2007, IT WAS DISCOVERED THAT THE PROXIMAL ESOPHAGUS WAS MARKEDLY NARROWED DUE TO SCARRING (DOWN TO 5-6MM PER THE OPERATIVE REPORT). PEG TUBE AND ESOPHAGEAL DILATATIONS ARE REQUIRED ABOUT EVERY SIX MONTHS. THE ENT (EAR, NOSE AND THROAT) PHYSICIAN COULD NOT UNDERSTAND WHY THERE WAS SEVERE SCARRING AS THE RADIATION DOSAGE REPORTED SEEMED APPROPRIATE. THE PATIENT INDICATED IN THE REPORT THAT AFTER READING SEVERAL NEWS ARTICLES REFERRING TO VARIAN'S EQUIPMENT, THE PATIENT BELIEVES THAT SHE HAS AN EXPLANATION FOR HER ADVERSE REACTION FOLLOWING TREATMENT. NO FURTHER PATIENT INFORMATION WAS SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE IYE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention