FDA Adverse Event Other Summary report: N

KENDALL DOVER

MDR report key: 691130 · Received March 22, 2006

Report

Report Number
1282497-2006-00012
Event Type
Other
Date Received
March 22, 2006
Date of Event
February 3, 2006
Report Date
February 7, 2006
Manufacturer
TYCO HEALTHCARE/KENDALL
Product Code
EZL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AS
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON FEBRUARY7, 2006 THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER STATES THAT A CATHETER WAS INSERTED INTO A MALE PT IN THE EMERGENCY DEPT- 101ML WAS INSERTED INTO BALLOON AND WITHIN 2 HRS, THE CATHETER WAS FOUND IN BED AND BALLOON HAD BURST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KENDALL DOVER 14FR SILICONE CATHETER, 5CC, 2-WAY EZL TYCO HEALTHCARE/KENDALL NA 5259283

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other