PARATREND 7 SENSOR MPS7004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1998-01-29 for PARATREND 7 SENSOR MPS7004 manufactured by Diametrics Medical, Ltd..

Event Text Entries

[122436] Blood leaked during insertion of the sensor. No report of injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-1998-90002
MDR Report Key146501
Report Source01,05,06
Date Received1998-01-29
Date of Report1998-01-27
Date of Event1997-12-16
Device Manufacturer Date1997-06-01
Date Added to Maude1998-02-03
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePARATREND 7 SENSOR
Generic NameBLOOD GAS MONITORING SYSTEM
Product CodeCCC
Date Received1998-01-29
Model NumberMPS7004
Catalog NumberMPS7004
Lot NumberNA
ID NumberNA
Device Expiration Date1998-05-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key142785
ManufacturerDIAMETRICS MEDICAL, LTD.
Manufacturer AddressGEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ
Baseline Brand NamePARATREND 7 SENSOR
Baseline Generic NameBLOOD GAS MONITORING SYSTEM
Baseline Model NoMPS7004
Baseline Catalog NoMPS7004
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-01-29

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