PALINDROME UNK DY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-30 for PALINDROME UNK DY manufactured by Covidien Mfg Solutions S.a..

Event Text Entries

[76159884] Submit date: 2017/may/30. An investigation is currently underway; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[76159885] It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states in the seventh week after insertion the patient returned to the facility for dialysis and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009211636-2017-05145
MDR Report Key6597726
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-05-30
Date of Report2017-05-03
Date Mfgr Received2017-05-03
Date Added to Maude2017-05-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN MFG SOLUTIONS S.A.
Manufacturer StreetEDIFICIO B20, CALLE #2
Manufacturer CityALAJUELA 0101
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALINDROME
Generic NameCATHETER, PERITONEAL DIALYSIS, SINGLE USE
Product CodeFKO
Date Received2017-05-30
Model NumberUNK DY
Catalog NumberUNK DY
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG SOLUTIONS S.A.
Manufacturer AddressEDIFICIO B20, CALLE #2 ALAJUELA 0101 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-30

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