FDA.reportPublic FDA data

MAUDE MDR 1456732

MDR report key
1456732
Report number
2936999-2009-00560
Event key
0
Event type
3
Date of event
2009-06-01
Date received
2009-08-26
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#

Contact
HOLLY GOMES, SUPERVISOR
Address
5870 STONERIDGE DR. SUITE 6 PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHILEY 6 DISPOSABLE CANNULA LOW PRESSURETRACHEOSTOMY TUBECOVIDIEN/FORMERLY TYCO HEALTHCAREBTO6DCTR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-08-2601. R

Event Narratives#

D

Patient 1

THE CALLER REPORTED THE CUFFS ON SEVEN TRACHEOSTOMY TUBES DEVELOPED LEAKS. ALL TRACHEOSTOMY TUBES HAD PRE-TESTED CUFFS INFLATED TO DIFFERENT PRESSURES DEPENDING ON THE PATIENT. THE LEAKS DEVELOPED BETWEEN 1 DAY AND 2 WEEKS INTO USE. THE TRACHEOSTOMY TUBES ARE ROUTINELY CHANGED MONTHLY, BUT NONE OF THESE RE INTUBATIONS OCCURRED ON ROUTINE CHANGE. THE TRACHEOSTOMY TUBES WERE ALL DISPOSED OF AND NO LOT NUMBERS ARE AVAILABLE. ASSOCIATED REPORTS: 2936999-2009-00561, 2936999-2009-00562, 2936999-2009-00563, 2936999-2009-00564, 2936999-2009-00565, 2936999-2009-00566.