FDA.reportPublic FDA data

MAUDE MDR 2900758

MDR report key
2900758
Report number
2900758
Event key
0
Event type
3
Date of event
2012-12-12
Date received
2013-01-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1HI SUMMITCARTHOWARD MEDICALNXB*** R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-01-030

Event Narratives#

D

Patient 1

SMOKE (NO FLAMES) CAME FROM EQUIPMENT. PATIENTS WERE EVACUATED FROM THE AREA AND THERE WAS NO HARM.