SWEAT CHLORIDE COLLECTION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-13 for SWEAT CHLORIDE COLLECTION SYSTEM manufactured by Wescor, Inc..

Event Text Entries

[4688] A 2-yr-old male pt had a sweat chloride test using the sweat chloride collection system. Upon completion of the exam, the negative electrode was removed from the right forearm and a small 1. 5 - 2. 0 mm necrotic area was observed. The area was diagnosed as a third degree burn and medical treatment was provided. The discs were used according to mfr's guidelines. Upon completion of the exam, the disc under the negative electrode was found to be split with a "bubbled" appearance. All other discs were normal in appearance. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, visual examination. Results of evaluation: telemetry failure, inherent risk of procedure. Conclusion: no failure detected and product within specification. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8128
• MDR Report Key: 8128
• Date Received: 1994-05-13
• Date of Report: 1994-05-10
• Date of Event: 1994-03-24
• Date Facility Aware: 1994-03-24
• Report Date: 1994-05-10
• Date Reported to FDA: 1994-05-10
• Date Reported to Mfgr: 1994-03-24
• Date Added to Maude: 1994-07-13
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SWEAT CHLORIDE COLLECTION SYSTEM
• Product Code: KTB
• Date Received: 1994-05-13
• Model Number: NA
• Catalog Number: NA
• Lot Number: 40522
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7803
• Manufacturer: WESCOR, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-05-13