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 |