FDA.reportPublic FDA data

MAUDE MDR 1601124

MDR report key
1601124
Report number
1317749-2010-00012
Event key
0
Event type
3
Date of event
2009-07-03
Date received
2010-01-29
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 STREET 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 EMERALD 19/36KIT VTHEMODIALYSIS CATHETERCOVIDIENNYU8888145043888145043819581Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-01-290

Event Narratives#

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON 1/29/2010, THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THE CATHETER CAME OUT OF THE PATIENT'S SITE ON (B)(6)2009, AFTER IMPLANTATION DATE (B)(6)2009. CATHETER WAS REPLACED, WITH NO ILL EFFECT TO THE PATIENT.

N

Patient 1

(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WIL BE FORWARDED.