FDA.reportPublic FDA data

MAUDE MDR 1978097

MDR report key
1978097
Report number
1317749-2011-00009
Event key
0
Event type
3
Date received
2011-01-07
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#

Contact
JUDITH SHAW, RN
Address
15 HAMPSHIRE ST. MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PALINDROME EMERALDHEMODIALYSIS CATHETERCOVIDIENNYUUNKUNK DY007110* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-01-070

Event Narratives#

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THEY HAD A PT WHERE THE CATHETER FELL OUT APPROX 4 WEEKS POST INSERTION. THE CUFF WAS REPORTEDLY EXPOSED AND STILL ATTACHED TO THE CATHETER. CATHETER HAD TO BE REPLACED WITH ANOTHER.

N

Patient 1

SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.