FDA.reportPublic FDA data

MAUDE MDR 6040502

MDR report key
6040502
Report number
6040502
Event key
0
Event type
3
Date of event
2015-11-14
Date received
2016-10-19
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
1OMNICELLMEDICAL COMPUTERS AND SOFTWAREOMNICELL, INC.LIBR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-190

Event Narratives#

N

Patient 1

D

Patient 1

OMNICELL WOULD NOT DISPENSE NORCO IN ED. THIS ITEM IS AVAILABLE IN MULTIPLE OMNICELLS. TO ADDRESS IMMEDIATE PATIENT ISSUE, PRODUCT COULD BE OBTAINED FROM OTHER OMNICELL. THE NEXT DAY, AM PHARMACY CHECKED AND FOUND NO PROBLEM WITH HYDROCODONE. NO HYDROCODONE WAS DISPENSED THAT DAY. THAT DAY, I VERIFIED THE FOLLOWING: HYDROCODONE WAS CYCLE COUNTED - COUNT WAS CORRECT. COIL CONTAINING HYDROCODONE WAS INSPECTED AND FOUND TO BE INTACT. HYDROCODONE WAS DESTOCKED AND RESTOCKED AND COIL FUNCTIONED AS EXPECTED.