FDA.reportPublic FDA data

MAUDE MDR 3244511

MDR report key
3244511
Report number
3244511
Event key
0
Event type
3
Date of event
2013-07-12
Date received
2013-07-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*GOWN, ISOLATIONKIMBERLY CLARKFYCKC20069979-87LG 3 132 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-160

Event Narratives#

D

Patient 1

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.