FEMORAL CATHETER MCF55PS*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2001-11-09 for FEMORAL CATHETER MCF55PS* manufactured by Medcomp Medical Components, Inc..

Event Text Entries

[18558223] It was reported that the catheter broke internally at home. The catheter had been implanted for two weeks. It was surgically removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518902-2001-00191
MDR Report Key360839
Report Source01,08
Date Received2001-11-09
Date of Report2001-09-21
Date of Event2000-12-01
Date Mfgr Received2001-09-21
Device Manufacturer Date1999-05-01
Date Added to Maude2001-11-26
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 FDA3
Event Location0
Manufacturer ContactSUSAN SMITH, RN
Manufacturer Street1499 DELP DRIVE
Manufacturer CityHARLEYSVILLE PA 19438
Manufacturer CountryUS
Manufacturer Postal19438
Manufacturer Phone2152564201
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFEMORAL CATHETER
Generic NameHEMODIALYSIS CATHETER
Product CodeLFK
Date Received2001-11-09
Returned To Mfg2001-10-01
Model NumberNA
Catalog NumberMCF55PS*
Lot NumberM915250
ID NumberNA
Device Expiration Date2004-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key349997
ManufacturerMEDCOMP MEDICAL COMPONENTS, INC.
Manufacturer Address1499 DELP DR HARLEYSVILLE PA 19438 US
Baseline Brand NameFEMORAL CATHETER
Baseline Generic Name.035 X 70CM J FLEX GUIDEWIRE
Baseline Catalog NoMCF55PS*
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]27
Baseline PMA FlagN
Baseline 510K PMNY
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-11-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.