* KC200 69979-87

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-16 for * KC200 69979-87 manufactured by Kimberly Clark.

Event Text Entries

[3688128] A nurse put an isolation gown on prior to entering room where a patient was in transmission based precautions. The left sleeve was found to be not sealed to gown. The opening was approximately 9 inches along the seam of the sleeve. ======================manufacturer response for isolation gown, kimberly clark isolation gown (per site reporter). ======================e-mail sent today to company rep. No response as of yet. What was the original intended procedure? Protect staff from exposure to infectious agents from patien in isolation room. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3244511
• MDR Report Key: 3244511
• Date Received: 2013-07-16
• Date of Report: 2013-07-16
• Date of Event: 2013-07-12
• Report Date: 2013-07-16
• Date Reported to FDA: 2013-07-16
• Date Reported to Mfgr: 2013-07-24
• Date Added to Maude: 2013-07-24
• 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: 3
• 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 Details

• Brand Name: *
• Generic Name: GOWN, ISOLATION
• Product Code: FYC
• Date Received: 2013-07-16
• Model Number: KC200
• Catalog Number: 69979-87
• Lot Number: LG 3 132
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBERLY CLARK
• Manufacturer Address: 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-16