GIBSON-COOKE SWEAT TEST IPS-6D *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-26 for GIBSON-COOKE SWEAT TEST IPS-6D * manufactured by Gibson-cooke.

Event Text Entries

[198735] Nurse performed sweat test on pt's right arm with black electrode on upper arm and red electrode on lower forearm. Nurse turned on power and raised the needle to 3. 5 milli "amos" gradually. Nurse placed thumb between both electrodes during test. Performed test for 5 mins and at end of test rn turned off power. When rn removed both electrodes and inspected pt's skin, a small 1 cm by 1/2 cm area of arm was burned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021504
• MDR Report Key: 323498
• Date Received: 2001-03-26
• Date of Report: 2001-03-26
• Date of Event: 2001-03-09
• Date Added to Maude: 2001-04-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GIBSON-COOKE SWEAT TEST
• Generic Name: SWEAT TEST
• Product Code: KTB
• Date Received: 2001-03-26
• Model Number: IPS-6D
• Catalog Number: *
• Lot Number: *
• ID Number: 0000124236
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 312978
• Manufacturer: GIBSON-COOKE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-03-26