IONIZING RADIATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-30 for IONIZING RADIATION manufactured by .

Event Text Entries

[20746332] Recommendation: real time radiation exposure program as financially inexpensive to implement. It is mandatory that the medical community determine the dose level of radiation because currently there is no independent monitor {sensor} that can accurately state how much ionizing radiation the pt is exposed to. To correct this deficiency is quite simple. First, the equipment provided by the mfr must have standard scientifically calibrated pre-programmed dosage settings for each type of bodily x-ray/scan. Each dosage setting must be imprinted on the x-ray. Second, an independent and separate radiation sensor must be located adjacent to the pt (there are none now) that will show the actual amount of ionizing radiation exposure received by the pt. [see below "monitoring and controlling exposure" for potential types of radiation sensing equipment. ] this independent dosage level must also be imprinted on the x-ray. The dosage setting from the mfr's equipment and the dosage reading from the independent sensor must be the same. Since the criteria for safe exposure limits is already published, the pt and the radiologist now have a permanent record of cumulative exposure so that they can safely schedule the next x-ray exam. Monitoring and controlling exposure: radiation has always been present in the environment and in our bodies. The human body cannot sense ionizing radiation, but a range of instruments exists which are capable of detecting even very low levels of radiation from natural and man-made sources. Dosimeters measure an absolute dose received over a period of time. Ion-chamber dosimeters resemble pens, and can be clipped to one's clothing. Film-badge dosimeters enclose a piece of photographic film, which will become exposed as radiation passes through it. Ion-chamber dosimeters must be periodically recharged, and the result logged. Film-badge dosimeters must be developed as photographic emulsion so the exposures can be counted and logged; once developed, they are discarded. Another type of dosimeter is the tld (thermoluminescent dosimeter). These dosimeters contain crystals that emit visible light when heated, in direct proportion to their total radiation exposure. Like ion-chamber dosimeters, tlds can be re-used after they have been 'read'. Geiger counters and scintillation counters measure the dose rate of ionizing radiation directly. Http://en. Wikipedia. Org/wiki/ionizing_radiation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018400
MDR Report Key1916849
Date Received2010-11-30
Date Added to Maude2010-12-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIONIZING RADIATION
Generic NameIONIZING RADIATION
Product CodeNON
Date Received2010-11-30
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-30

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