UNKNOWN PERITONEAL CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,user facilit report with the FDA on 2019-10-28 for UNKNOWN PERITONEAL CATHETER manufactured by Covidien Mfg Solutions S.a..

MAUDE Entry Details

Report Number3009211636-2019-00234
MDR Report Key9248346
Report SourceCONSUMER,FOREIGN,USER FACILIT
Date Received2019-10-28
Date of Report2019-10-28
Date of Event2019-10-08
Date Mfgr Received2019-10-11
Date Added to Maude2019-10-28
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 STREET
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 NameUNKNOWN PERITONEAL CATHETER
Generic NameCATHETER, PERITONEAL, LONG-TERM INDWELLING
Product CodeFJS
Date Received2019-10-28
Model NumberUNKNOWN PERITONEAL CATHETER
Catalog NumberUNKNOWN PERITONEAL CATHETER
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. Required No Informationntervention 2019-10-28

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