NEOTREND-L SENSOR N7004-L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-06-10 for NEOTREND-L SENSOR N7004-L manufactured by Diametrics Medical, Ltd..

Event Text Entries

[400700] The user was unable to insert the neotrend-l sensor into the umbilical artery catheter (vac). The sensor was removed and returned to the mfr for investigation. No report of adverse event or pt-related problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-2004-00010
MDR Report Key594176
Report Source07
Date Received2004-06-10
Date of Report2004-05-07
Date of Event2004-05-05
Date Mfgr Received2004-05-21
Device Manufacturer Date2003-10-01
Date Added to Maude2005-04-25
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 ContactMISS J. WALTERS
Manufacturer StreetSHORT STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112QH
Manufacturer CountryUK
Manufacturer PostalHP11 2QH
Manufacturer Phone494471671
Manufacturer G1DIAMETRICS MEDICAL LIMITED
Manufacturer StreetGEORGE STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112XJ
Manufacturer CountryUK
Manufacturer Postal CodeHP11 2XJ
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNEOTREND-L SENSOR
Generic NameBLOOD GLAS MONITORING SYSTEM
Product CodeCCE
Date Received2004-06-10
Returned To Mfg2004-05-11
Model NumberN7004-L
Catalog NumberN7004-L
Lot Number907
ID Number*
Device Expiration Date2005-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key584003
ManufacturerDIAMETRICS MEDICAL, LTD.
Manufacturer AddressGEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ
Baseline Brand NameNEOTREND-L SENSOR
Baseline Generic NameBLOOD GLAS MONITORING SYSTEM
Baseline Model NoN7004-L
Baseline Catalog NoN7004-L
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2004-06-10

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