FARRALL INSTRUMENTS SWEAT CHLORIDE POTENTIOMETER IPS-25-A NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-08 for FARRALL INSTRUMENTS SWEAT CHLORIDE POTENTIOMETER IPS-25-A NONE manufactured by Farrall Instruments.

Event Text Entries

[50005] During sweat chloride procedure, the negative electrode left a small burn on pt's arm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1011111
MDR Report Key82081
Date Received1997-04-08
Date of Report1997-03-31
Date of Event1997-03-19
Date Added to Maude1997-04-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFARRALL INSTRUMENTS SWEAT CHLORIDE POTENTIOMETER
Generic NameSWEAT CHLORIDE POTENTIOMETER
Product CodeKTB
Date Received1997-04-08
Model NumberIPS-25-A
Catalog NumberNONE
Lot NumberNONE
ID NumberNONE
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key81484
ManufacturerFARRALL INSTRUMENTS
Manufacturer Address3724 ARCH AVE GRAND ISLAND NE 68803 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 1997-04-08

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