CT SCANNER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-18 for CT SCANNER manufactured by .

Event Text Entries

[70682174] I went in to (b)(6) medical clinic in (b)(6) for a ct scan on my abdomen/pelvis ordered by my doctor, not being made aware by any of the physicians that this was any different from a blood test or strep test or any other routine exam. Within a few hours after the scan, i began to get these clear/gray hairs popping up around my head that did not flow in a consistent direction with my other hair. I also had severe stomach cramps, which i assumed were related to the oral contrast consumed prior to the scan. Over the following two days, the look and feel of my hair changed dramatically. Other people (family, friends, coworkers, customers) noticed and were concerned. I even had customers start asking about the potential for someone else to be added to the project i was working in case i was unavailable at some point in the future. I also lost a very large amount of hair when showering in the days following the scan. Much of the hair loss occurred on the sides and in the back of my head. I made an appointment with my doctor (who works for the clinic with the ct scanner used for the scan) and he told me that it is more likely from anxiety and sent me home. The nurse asked if i was sure that this began after the scan, and i emphatically said "yes". The doctor told me to wait a couple of months and it should go back to normal. After 2 plus months, my hair was still in this condition, so i called back and was told the same story. I am not sure who to contact at this point. I additionally recall having redness on my abdomen the morning after the scan, but i dismissed it as "coincidence", along with most of the other symptoms at the time because the doctors and technicians gave no indication that there could be any possible side effects. I am not sure what happened. I contacted the nc radiation protection commission in february, and the representative said that the facility was due for an inspection. I was told to send them an email describing the situation and that an inspection would be done. Several weeks later, i was notified that the facility was inspected and was not found in violation of any codes. I am not sure who to contact at this point. There does not seem to be a great deal about this happening before when browsing the web, except for situations with head cts, which i have no read to be much more common and typically use less radiation than an abdominal/pelvic scan. I have also wondered if the age of most patients there is typically much older and so maybe changes in hair consistency and color might be less noticeable. The machine was an open ct scanner, which i have had some difficulty finding much about on the web. I just turned (b)(6) and i feel like i was misled by physicians and other medical personnel about this scan. I experienced some very strange symptoms in the hours and days following the scan and none of the office personnel have given me any indication that they are taking this seriously, even going to the point of being sarcastic about it. I contacted another doctor's office to schedule an appointment to get another (maybe less biased) view on it, but the wait to see a new doctor was at least several weeks. Prior to this, i thought that doctors were more concerned with a patient's well-being and did not really consider the fact that the medical industry is a money-making business, and that doctors and medical personnel would be interested in something other than what is best for the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068561
MDR Report Key6423847
Date Received2017-03-18
Date of Report2017-03-18
Date of Event2016-12-29
Date Added to Maude2017-03-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCT SCANNER
Generic NameCT SCANNER
Product CodeOUO
Date Received2017-03-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0

Device Sequence Number: 1

Brand NameCT SCANNER
Generic NameCT SCANNER
Product CodeLLZ
Date Received2017-03-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-03-18

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