KC200 ISOLATION GOWN KC 200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-23 for KC200 ISOLATION GOWN KC 200 * manufactured by Kimberly-clark.

Event Text Entries

[18848911] The new isolation gowns have holes in sleeve where it attaches to shoulder and have no elastic at the cuff. We had switched to this particular gown and had problems at that time. No gowns were given to this reporter and no lot numbers were provided but the manufacturer field representative was aware. Problem seemed to resolve until early this year when infection control collected about 30 of the brand new gowns with this problem. Staff would open the new package, take out the disposable gown, try to put it on and discover the hole or the missing elastic. All had same lot numbers. Staff did not use the defective gown when entering the isolation room, so no exposures occurred because of this. ======================manufacturer response for isolation gowns, kc200 isolation gown (per site reporter)======================the field representative picked up several of the affected gowns and suggested we use a different gown that we have on stock. However, that gown does not work for everyone as it is way too big. This gown (the yellow one) is used by the majority of our staff. The field representative had mentioned that another hospital was also having this problem. A letter was received from global post market surveillance thanking us for our feedback and apologizing for our inconvenience. Nothing was said about a solution or resolution to the problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2554667
• MDR Report Key: 2554667
• Date Received: 2012-04-23
• Date of Report: 2012-04-23
• Date of Event: 2012-03-28
• Report Date: 2012-04-23
• Date Reported to FDA: 2012-04-23
• Date Added to Maude: 2012-05-01
• 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 Details

• Brand Name: KC200 ISOLATION GOWN
• Generic Name: ISOLATION GOWNS
• Product Code: OEA
• Date Received: 2012-04-23
• Returned To Mfg: 2012-04-16
• Model Number: KC 200
• Catalog Number: *
• Lot Number: 69979-97
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBERLY-CLARK
• Manufacturer Address: 1300 ORCHARD HILL RD. LAGRANGE GA 30240 US 30240

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-23