MAUDE MDR 4874027

MDR report key
4874027
Report number
1954182-2015-00002
Event key
0
Event type
3
Date of event
2015-06-05
Date received
2015-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KATHLEEN SMITH
Address
200 NW PKWY. RD. RIVERSIDE MO 64150 US
Phone
330-330-3303
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DUO FLEX FLUID CART SMOKEDUO FLEX FLUID CART SMOKEDORNOCH MEDICALFLHNAUL-DU500SENAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-250

Event Narratives#

D

Patient 1

IT WAS REPORTED FROM EMPLOYEE HEALTH AT THE USER FACILITY THAT A HOSPITAL STAFF MEMBER CUT HER FINGER WHILE CLEANING THE DUO FLEX FLUID CART WITH SMOKE EVACUATOR. IT WAS STATED THAT THE INDIVIDUAL CUT HER FINGER ON THE LIP OF THE CL HOUSING WHILE WIPING DOWN THE UNIT. THE CUSTOMER INQUIRED ABOUT POTENTIAL EXPOSURE. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

N

Patient 1

THE DEVICE WAS INSTALLED ON (B)(6) 2015 AND HAS NO REPAIR HISTORY WITH ZIMMER. THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION OR REPAIR BY ZIMMER. THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED AND A CAUSE COULD NOT BE DETERMINED.