ISOLATION GOWN KC200 69979

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-18 for ISOLATION GOWN KC200 69979 manufactured by Kimberly-clark Corporation.

Event Text Entries

[21988208] New package of isolation gowns found to have sleeves sealed shut and seams not sealed. Unable to use them for protection of staff going into isolation rooms. No staff used a defective gown, but potential for exposure is high if staff not aware that seams are open. Seems to be an intermittent problem as this occurred in the fall of 2011 and again in the spring of 2012. ======================manufacturer response for isolation gowns, isolation gown (per site reporter). ======================no response yet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2897200
MDR Report Key2897200
Date Received2012-12-18
Date of Report2012-12-18
Date of Event2012-12-10
Report Date2012-12-18
Date Reported to FDA2012-12-18
Date Added to Maude2013-01-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameISOLATION GOWN
Generic NameGOWN, ISOLATION, SURGICAL
Product CodeFYC
Date Received2012-12-18
Model NumberKC200
Catalog Number69979
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORPORATION
Manufacturer Address1400 HOLCOMB BRIDGE ROAD ROSWELL, GA 30076 GA 30076 US 30076


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-18

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