FDA.reportPublic FDA data

MAUDE MDR 538292

MDR report key
538292
Report number
1824231-2004-00004
Event key
0
Event type
3
Date of event
2004-03-11
Date received
2004-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
5700 W. 23RD AVE GARY IN 46406 US
Phone
219-219-2199
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIVONACRICOTHYROTOMY DEVICESMITHS MEDICAL ASD, INC.BWC*B10100UNKK790650NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-03-300

Event Narratives#

D

Patient 1

USED THE NU-TRAKE LAST NIGHT ON A PT AND THE DR REPORTED THAT IT BROKE AND HE HAD TO MANUALLY RETRIEVE A PIECE FROM THE PT'S TRACHEA.