MACRODUCT 3700 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-19 for MACRODUCT 3700 * manufactured by Wescor, Inc..

Event Text Entries

[631603] Patient was seen for a sweat chloride test. The cause is unknown, however patient sustained an injury to his arm where the pilogel disc/electrode was placed to perform the test. This reaction was discovered after the five-minute sweat stimulation was completed and pilogel disc was removed. Patient was evaluated in the emergency department. It was noted that the patient had a 2-3mm lesion that was dark in color and appeared to be consistent with a burn. The marcoduct system was evaluated by the biomed department and determined to operate as designed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 871066
• MDR Report Key: 871066
• Date Received: 2007-06-19
• Date of Report: 2007-06-19
• Date of Event: 2007-06-07
• Report Date: 2007-06-19
• Date Reported to FDA: 2007-06-19
• Date Added to Maude: 2007-06-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MACRODUCT
• Generic Name: SWEAT COLLECTION SYSTEM
• Product Code: CGZ
• Date Received: 2007-06-19
• Model Number: 3700
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 851730
• Manufacturer: WESCOR, INC.
• Manufacturer Address: 459 SOUTH MAIN STREET LOGAN UT 84321 US

Device Sequence Number: 2

• Brand Name: MACRODUCT
• Generic Name: SWEAT COLLECTION SYSTEM
• Product Code: KTB
• Date Received: 2007-06-19
• Model Number: 3700-SYS
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 851731
• Manufacturer: WESCOR, INC.
• Manufacturer Address: 459 SOUTH MAIN STREET LOGAN UT 84321 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-06-19