FDA Adverse Event Malfunction Summary report: N

NANODOTS

MDR report key: 2299784 · Received October 12, 2011

Report

Report Number: MW5022660
Event Type: Malfunction
Date Received: October 12, 2011
Date of Event: October 1, 2011
Report Date: October 12, 2011
Manufacturer: LANDAUER, INC
Product Code: LHO
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

WE HAVE BEEN USING LANDAUER NANO DOTS FOR PT DOSIMETRY. WE HAVE RUNG YOUR DEPT FOR COPY OF THE LISTING AND WAS ADVISED THERE WAS NONE. WE ASKED THE LANDAUER PEOPLE TO SUPPLY US WITH CE CERTIFICATION. WE HAVE RECEIVED A LOT OF PAPERWORK WHICH DOES NOT AGREE AND IS VERY GENERIC. WE NOTE THAT THE READERS ARE MADE IN (B)(4) BUT REBADGED MADE IN USA AND THE READER IS MARKED WITH CE APPROVAL STICKERS. OUR MAIN CONCERN, HOWEVER, IS THE NANO DOTS BEING ADVERTISED FOR INVIVO APPLICATIONS BUT THERE IS NO SUPPORTING DOCUMENTATION THAT THE PRODUCT HAS CE OR FDA APPROVAL WHICH IS NEEDED FOR OUR HOSPITAL TO FULFILL OUR QUALITY PROGRAM AND PURCHASE THESE DOTS. ESPECIALLY WHEN THE PRODUCT IS AFFIXED TO PTS' BODIES AND PLACED IN PTS' BODY CAVITIES DURING TREATMENT. WE HAVE FAILED TO RECEIVE ANY MATERIAL SUCH AS A SAFETY DATA SHEET CONFIRMING THAT THE CHEMISTRY WILL NOT SUFFER DEGRADATION DURING A RADIOTHERAPY TREATMENT. THE PRODUCT IS ADVERTISED WORLDWIDE AS A RADIOTHERAPY AND DIAGNOSTIC DOSIMETER FOR INVIVO APPLICATIONS. THE PUBLICATIONS ON THE LANDAUER WEBSITE SHOW THE DOTS BEING USED ON PTS AND CONFIRM USE FOR INVIVO APPLICATIONS. WWW.LANDAUER.COM I STOPPED USING THESE DOTS AS I AM CONCERNED I MIGHT GET INTO TROUBLE. NANO DOTS ALSO ARE THEIR PERSONNEL DOSIMETERS FOR RADIATION WORKERS REQUIRE SIMILAR APPROVALS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NANODOTS	NANODOTS MICROSTAR READER	LHO	LANDAUER, INC	NANODOT

Patients

Seq	Age	Sex	Outcome	Treatment
1