FDA.reportPublic FDA data

MAUDE MDR 1569042

MDR report key
1569042
Report number
1018233-2009-00160
Event key
0
Event type
3
Date of event
2009-11-25
Date received
2009-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NYCOLE SAYER
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD URINE METER FOLEY TRAYC.R. BARD, INC.EXRNA903116ANGTG2493Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-12-3101. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A DISORIENTED PATIENT'S LEG WAS LACERATED BY THE DRAIN BAG HANGER WHEN ATTEMPTING TO GET OUT OF THE BED WHILE THE BED RAIL WAS IN THE UP POSITION. THE LACERATION OCCURRED TO THE BACK OF THE LEG, PATIENT WAS TAKEN TO THE ER FOR SUTURING. THE FACILITY REPORTED THAT THE BAG WAS IMPROPERLY HUNG ON THE TOP PORTION OF THE BED RAIL WHILE THE PATIENT WAS BEING TRANSPORTED.

N

Patient 1

AS OF TODAY'S DATE, THE SAMPLE HAS BEEN RECEIVED BUT IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING SITE. THE DHR WAS REVIEWED AND THERE IS NO EVIDENCE OF ANY MANUFACTURING ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES "POSITION HANGER ON BEDSIDE RAIL NEAR THE FOOT OF THE BED USING SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET." A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SAMPLE INVESTIGATION IS COMPLETE.