FDA.reportPublic FDA data

MAUDE MDR 6308408

MDR report key
6308408
Report number
MW5067721
Event key
0
Event type
3
Date of event
2017-01-12
Date received
2017-02-06
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
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1METAL TRAYMETAL TRAYUNKLRPUNKI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-060

Event Narratives#

D

Patient 1

METAL TRAY WAS BROUGHT INTO MRI ROOM AND WAS STUCK TO THE MAGNET. TRAY WAS LABELED FOR NON-MRI. THIS WAS HUMAN ERROR. NO PATIENT OR EMPLOYEE WAS HURT.