FDA Adverse Event
Other
Summary report: N
LATEX FOLEY CATHETER
MDR report key: 4567616
·
Received February 27, 2015
Report
- Report Number
- 1018233-2015-00066
- Event Type
- Other
- Date Received
- February 27, 2015
- Date of Event
- February 4, 2015
- Report Date
- February 6, 2015
- Manufacturer
- C.R. BARD, INC. (MONCKS)
- Product Code
- EZC
- PMA / PMN Number
- K910846
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BALLOON WAS INFLATED WHILE IN THE PT'S URETHRA. THE UROLOGIST WAS CALLED TO DO A CYSTOSCOPY TO INSERT THE FOLEY CATHETER. THE PT WOULD HAVE HAD FOLEY REMOVED POST OPERATIVE ON DAY #1, HOWEVER, HAD TO BE DISCHARGED HOME WITH THE FOLEY CATHETER WITH AN ANTICIPATED INDWELLING TIME OF 5-6 DAYS; F/U WILL TAKE PLACE ON AN OUTPUT BASIS WITH THE UROLOGY OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140838 | LATEX FOLEY CATHETER | EZC | C.R. BARD, INC. (MONCKS) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |