NANODOTS MICROSTAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-12 for NANODOTS MICROSTAR manufactured by Landauer, Inc.

Event Text Entries

[2285024] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022660
MDR Report Key2299784
Date Received2011-10-12
Date of Report2011-10-12
Date of Event2011-10-01
Date Added to Maude2011-10-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNANODOTS
Generic NameNANODOTS MICROSTAR READER
Product CodeLHO
Date Received2011-10-12
Model NumberNANODOT
Catalog NumberMICROSTAR
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerLANDAUER, INC
Manufacturer AddressGLEN WOOD IL US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-12

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