FDA.reportPublic FDA data

MAUDE MDR 8412038

MDR report key
8412038
Report number
8412038
Event key
0
Event type
3
Date of event
2018-12-10
Date received
2019-03-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1ECOLAB ORS 100 FLUID WARMER DRAPEDRAPE, SURGICALECOLABKKXORS100361374* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-120

Event Narratives#

D

Patient 1

PATIENT WAS HAVING A CREATION OF AN OSTOMY PROCEDURE. THERE WAS A STERILE WARMER DRAPE USED THROUGHOUT THE ENTIRE CASE. AFTER THE PROCEDURE, STAFF WERE CLEANING THE OPERATING ROOM SURGERY ROOM AND NOTED THAT UPON LIFTING THE WARMER DRAPE UP, THERE WAS A SMALL HOLE IN THE BOTTOM OF THE DRAPE. THERE WAS NO SALINE IN THE WARMER, ONLY WHEN THE WARMER DRAPE WAS LIFTED UP WAS THE SMALL HOLE NOTED. WARMER WAS USED TO IRRIGATE AND FOR WARM LAPS/RAYTEC. NO INJURY NOTED. SCRUB RN REPORTED NO LEAKAGE OF FLUID THROUGH THE DRAPE ALTHOUGH A HOLE WAS VISIBLE AFTER REMOVING THE DRAPE. HEATING ELEMENT WAS FULL. THE FLUID WAS NOT USED UNTIL AFTER THE WOUND CLOSURE, JUST TO CLEAN THE PATIENT'S SKIN.