PALINDROME 8888145039P

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 2020-02-17 for PALINDROME 8888145039P manufactured by Covidien Mfg Solutions S.a..

MAUDE Entry Details

Report Number3009211636-2020-00049
MDR Report Key9717830
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-17
Date of Report2020-03-26
Date of Event2020-01-29
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-01-07
Date Added to Maude2020-02-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
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 NamePALINDROME
Generic NameCATHETER, HEMODIALYSIS, IMPLANTED
Product CodeMSD
Date Received2020-02-17
Returned To Mfg2020-02-11
Model Number8888145039P
Catalog Number8888145039P
Lot Number1833800160
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG SOLUTIONS S.A.
Manufacturer AddressEDIFICIO B20, CALLE #2 ALAJUELA 20101 20101


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

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