MAUDE Adverse Event Report: CAT SCAN; SYSTEM, X-RAY, TOMOGRAPHY COMPUTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sweating (2444); Radiation Exposure, Unintended (3164); Fibrosis (3167)

Event Type  No Answer Provided  

Event Description

I am writing to report what i consider to be an overuse of cat scan radiation that may have caused my present incurable illness of myelo fibrosis, and is regarded as terminal.For this purpose, i am enclosing a copy of a letter that i sent to the fda, the american society of hematology and a leading researcher at the (b)(6) clinic.Thank you for consideration of this matter.In 1991 i was diagnosed with essential thrombocytosis.A series of hematologists treating me prescribed an 81mg aspirin tablet daily.From 1991 to 2012 i never had any adverse symptom or problem with the et.By 2012 my platelets were in normal range.I developed a bladder condition in 2012 that required surgery.The surgery was performed in (b)(6) 2013, but complications resulted in further surgeries and treatment.During the course of these multiple surgeries and treatments, i received five (5) cat-scans between (b)(6) 2013 and (b)(6) 2014.The total of these 5 cat scans was 64 msv.The 4th and 5th scans occurred on (b)(6) 2014 and two weeks later on (b)(6) 2014.About a week after these final two scans, i woke up one morning drenched with sweat.My hematologist conducted a bone marrow biopsy which resulted with a finding that my 21 year course of et had degraded into mf.I am concerned that the mf may have resulted from the scans.This is because i later learned that there is less than a 5% chance of a 21 year course of et turning into mf.At the same time i learned that mf can result from exposure to ionized radiation.I'll never know for sure whether my hypothesis is valid.But i am just concerned that pts such as me with et should be wary of being exposed to 5 cat scans within 10 months (including 2 coming within a two week period).

• Brand Name: CAT SCAN
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY COMPUTED
• MDR Report Key: 8591524
• MDR Text Key: 144676444
• Report Number: MW5086468
• Device Sequence Number: 2
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/12/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1