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MAUDE MDR 3062647

MDR report key
3062647
Report number
3062647
Event key
0
Event type
3
Date of event
2013-04-10
Date received
2013-04-11
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 3 041 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-110

Event Narratives#

D

Patient 1

TWO ISOLATION GOWNS WITHOUT ELASTIC ON CUFF TO HOLD TIGHT TO WRIST. ONE OF THE GOWNS HAS ELASTIC ON IT BUT NOT SECURED AND THE OTHER GOWN HAS NO ELASTIC AT THE LEFT WRIST AT ALL.======================MANUFACTURER RESPONSE FOR ISOLATION GOWN, KIMBERLY CLARK ISOLATION GOWN (PER SITE REPORTER).======================E-MAIL TO COMPANY REP, NO RESPONSE YET.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROTECT STAFF FROM EXPOSURE TO INFECTIOUS AGENTS FROM A PATIENT IN AN ISOLATION ROOM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.