BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVD MODEL #1136

    MDR report key: 2280320 · Received September 30, 2011

    Report

    Report Number
    MW5022488
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 30, 2011
    Manufacturer
    SUN NUCLEAR CORPORATION
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, WE PERFORMED IN VIVO DOSIMETRY TO VERIFY THE SKIN DOSE FOR THE PT'S TOTAL SKIN ELECTRON BEAM TREATMENT. WE USED (B)(4) IN VIVO DOSIMETRY DEVICE (IVD) MODEL #1136, WITH 8 CHANNELS AND RF CAPABILITY. EIGHT DETECTORS, SUPPLIED WITH THE DEVICE, WERE PLACED ON THE PT'S SKIN UNDER MY SUPERVISION. THEN, THE PRESCRIBED ELECTRON BEAM TREATMENT WAS ADMINISTERED WHILE DOSE RECORDING WAS TAKING PLACE. DURING THE RADIATION TREATMENT, THE PT NOTICED PAIN AND BURNING AT THE SITES OF DETECTORS CONTACTING THE SKIN. SHE REPORTED PAIN AND BURNING AT MULTIPLE DETECTORS SITES, ALTHOUGH SHE WAS NOT CERTAIN IF ALL 8 SITES OF CONTACT OF THE DETECTORS WITH THE SKIN WERE AFFECTED. I INSPECTED THE PT IMMEDIATELY AFTER THE RADIATION TREATMENT WAS ADMINISTERED AND THE DETECTORS WERE REMOVED FROM HER SKIN. THERE WAS AN AREA OF ERYTHEMA WITH IRREGULAR PALE SKIN ELEVATION ON HER POSTERIOR NECK AT THE SITE OF THE DETECTOR #4. THIS WAS MOST CONSISTENT WITH A SUPERFICIAL ELECTRON BURN. A SIMILAR BURN, BUT WITHOUT SKIN PALLOR, WAS PRESENT ON THE ANTERIOR ABDOMEN AT THE SITE OF THE DETECTOR #5 CONTACT WITH THE SKIN. VISIBLE BURNS WERE NOT PRESENT AT THE REMAINDER OF THE DETECTOR SITES. PT REPORTED NO OTHER COMPLAINTS AND EXHIBITED NO OTHER ADVERSE SIGNS. DIGITAL PHOTOGRAPHS WERE TAKEN BY ME IMMEDIATELY AFTER THE EVENT IN ORDER TO DOCUMENT IT. I TREATED THE BURN SITES ON THE POSTERIOR NECK AND ANTERIOR ABDOMEN WITH 2% TOPICAL LIDOCAINE CREAM AND SHE WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVD MODEL #1136 IVD MODEL #1136 IYE SUN NUCLEAR CORPORATION 1136 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other