DIALYSIS UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-09-04 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..

MAUDE Entry Details

Report Number3009211636-2019-00195
MDR Report Key8962481
Report SourceFOREIGN,LITERATURE
Date Received2019-09-04
Date of Report2019-09-04
Date of Event2018-11-01
Date Mfgr Received2019-08-08
Date Added to Maude2019-09-04
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 ContactLISA HERNANDEZ
Manufacturer Street15 HAMPSHIRE ST.
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG SOLUTIONS S.A.
Manufacturer StreetEDIFICIO B20, CALLE #2
Manufacturer CityALAJUELA 20101
Manufacturer Postal Code20101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIALYSIS UNKNOWN
Generic NameCATHETER, PERITONEAL, LONG-TERM INDWELLING
Product CodeFJS
Date Received2019-09-04
Model NumberDIALYSIS UNKNOWN
Catalog NumberDIALYSIS UNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG SOLUTIONS S.A.
Manufacturer AddressEDIFICIO B20, CALLE #2 ALAJUELA 20101 20101


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2019-09-04

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