* 69979-87 TM 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 2013-04-24 for * 69979-87 TM KC 200 manufactured by Kimberly-clark.

Event Text Entries

[3265634] A nurse tried to put on isolation gown to enter a room and found the elastic at the wrist was not secured, so the sleeve was not tight to her arm. ======================manufacturer response for isolation gown, kimberly clark isolation gown (per site reporter). ======================e-mail to company rep not yet responded to. What was the original intended procedure? Protect staff from exposure to infectious agents from patients 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 Number3082101
MDR Report Key3082101
Date Received2013-04-24
Date of Report2013-04-24
Date of Event2013-04-17
Report Date2013-04-24
Date Reported to FDA2013-04-24
Date Reported to Mfgr2013-04-29
Date Added to Maude2013-04-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameGOWN, ISOLATION
Product CodeFYC
Date Received2013-04-24
Model Number69979-87
Catalog NumberTM KC 200
Lot NumberLG 3 017
ID Number*
OperatorNURSE
Device AvailabilityR
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK
Manufacturer Address1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-24

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