FDA.reportPublic FDA data

MAUDE MDR 474759

MDR report key
474759
Report number
474759
Event key
0
Event type
3
Date of event
2003-02-01
Date received
2003-07-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*LEAD FILTER*ITY***NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-07-2801. O

Event Narratives#

D

Patient 1

PT WAS ON THE X-RAY TABLE FOR THORACIC AND LUMBAR SPINE X-RAYS. WHILE THE AP VIEW OF THE THORACIC SPINE WAS BEING PERFORMED, A LEAD FILTER WAS PLACED ON THE BOTTOM OF THE X-RAY TUBE. THE FILTER WAS SLIGHTLY BENT ON THE EDGES AND DID NOT FIT WELL. UPON REMOVING THE FILTER, IT FELL AND STRUCK THE PT IN THE MID-CHEST. THE PT STATED THAT IT STRUCK THEM ON THE LEFT MEDIAL LOWER PORTION OF THEIR LEFT BREAST AND THE RIGHT MEDIAL UPPER PORTION OF THEIR RIGHT BREAST.