FDA.reportPublic FDA data

MAUDE MDR 7463846

MDR report key
7463846
Report number
1518293-2018-00011
Event key
0
Event type
3
Date of event
2018-03-29
Date received
2018-04-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
113
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
FRED RECKELHOFF
Address
2111 E. GALBRAITH RD OH 45237 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUT EXT DR FINAL ASSY-STANDARDHUT EXT DR FINAL ASSY-STANDARDLIEBEL-FLARSHEIMIXR404008* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-260

Event Narratives#

D

Patient 1

WHEN IN A PROCEDURE: THEY WERE USING THE FLUORO PEDAL AND THEY TOOK THEIR FOOT OFF THE PEDAL AND IT WOULD NOT STOP FLUOROING. THE STAFF HAD TO HIT THE EMERGENCY STOP BUTTON. THEY STATED THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. NO ADVERSE EFFECTS ON PATIENTS AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.