OZ TWH 99 DBC2 8888411009

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-10-11 for OZ TWH 99 DBC2 8888411009 manufactured by Covidien.

Event Text Entries

[2338673] It was reported to covidien on (b)(6) 2011 that a customer had an issue with a peritoneal dialysis catheter. On (b)(6) 2011 after implantation of the catheter the doctor performed the usual evaluation of the position and if the catheter is working as expected. Xray taken and no flow could be detected from the lower part of the catheter. Catheter was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5


[9374237] An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1317749-2011-00254
MDR Report Key2313280
Report Source01,06
Date Received2011-10-11
Date of Report2011-09-12
Report Date2011-09-12
Date Reported to Mfgr2011-09-12
Date Mfgr Received2011-09-12
Date Added to Maude2012-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJUDITH SHAW, RN
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street5439 STATE ROUTE 40
Manufacturer CityARGYLE NY 12809
Manufacturer CountryUS
Manufacturer Postal Code12809
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOZ TWH 99 DBC2
Generic NamePERITONAL DIALYSIS CATHETER
Product CodeFKO
Date Received2011-10-11
Model Number8888411009
Catalog Number8888411009
Lot Number921251
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-11

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