NUCLEAR IMAGER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-02 for NUCLEAR IMAGER manufactured by .

Event Text Entries

[20924772] Reporter states he was admitted to hospital for heart condition. On the third day of hospitalization, he had a stress test performed. During first scan, reporter requested not to have cushion placed underneath legs. During his second scan, technician placed cushion underneath reporter's legs without his approval. As the machine turned in a clockwise motion, his left knee was moved towards his right knee. Reporter says that his gown was caught in the machine and pulled down on the reporter's knee. The reporter mentioned this to the technician and the technician said alright hold on and then stopped the machine. Reporter was taken to hospital room, then to x-ray. Reporter was given a knee immobilizer and immediately discharged and placed in a taxi. Reporter says he has contusions, bruising and is still in pain and is currently on his couch unable to move. Reporter says he has spoken to a hospital rep and was told that an incident report has been filed. Hospital.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5011250
MDR Report Key	1397186
Date Received	2009-06-02
Date of Report	2009-06-02
Date of Event	2009-05-28
Date Added to Maude	2009-06-08
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Generic Name	NUCLEAR IMAGER
Product Code	IYX
Date Received	2009-06-02
Device Availability	N
Device Sequence No	1
Device Event Key	0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-02