BEUDAMED
    FDA Adverse Event Other Summary report: N

    NANODOT

    MDR report key: 2498552 · Received December 14, 2011

    Report

    Report Number
    3008426232-2011-00001
    Event Type
    Other
    Date Received
    December 14, 2011
    Report Date
    December 20, 2011
    Manufacturer
    LANDAUER INC
    Product Code
    LHO
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) PURCHASED THE LDR NANODOT AND MICROSTAR DOSIMETRY SYSTEM TO MAKE IN VIVO DOSE MEASUREMENTS. THE CUSTOMER REPORTED THAT THEIR HOSP REQUIRES THE FDA REGISTRATION AND CE INFO FOR THE NANODOT/MICROSTAR DOSIMETRY SYSTEM AS PART OF THEIR QUALITY ASSURANCE PROGRAM. IN RESPONSE, OUR SUBSIDIARY IN (B)(4) CONTACTED THE CUSTOMER TO PROVIDE OUR FDA REGISTRATION NUMBER, AND CE INFO (B)(4). THE CUSTOMER ALSO REPORTED THAT THEY ARE USING THE NANODOT WITHIN A PT BODY CAVITY. WE DO NOT LABEL OR RECOMMEND THE USE OF THE NANODOT WITHIN A PT BODY CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANODOT OSL DOSIMETER LHO LANDAUER INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1