FDA Adverse Event
Injury
Summary report: N
FOLEY STANDARD 3-WAY 22FR. 30ML BALLOON
MDR report key: 1550552
·
Received November 30, 2009
Report
- Report Number
- 2130787-2009-00008
- Event Type
- Injury
- Date Received
- November 30, 2009
- Date of Event
- November 11, 2009
- Report Date
- November 24, 2009
- Manufacturer
- ROCHESTER MEDICAL CORP.
- Product Code
- EZL
- PMA / PMN Number
- K981612
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6)2009, IT WAS REPORTED TO A ROCHESTER MEDICAL SALES REPRESENTATIVE THAT A PATIENT WAS ADMITTED INTO AN OPERATING ROOM TO HAVE A FOLEY CATHETER REMOVED. IT WAS REPORTED THAT THE ATTENDING PHYSICIAN REMOVED THE CATHETER BY DEFLATING THE CATHETER BALLOON AND PULLING THAT CATHETER OUT OF THE URETHRAL TRACT. UPON REMOVAL OF THE CATHETER, THE PATIENT EXPERIENCED BLEEDING. THE FOLEY CATHETER USED BY THE PATIENT WAS RETURNED TO ROCHESTER MEDICAL FOR EVALUATION ON 11/19/2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOLEY STANDARD 3-WAY 22FR. 30ML BALLOON | FOLEY STANDARD 3-WAY URINARY CATHETER | EZL | ROCHESTER MEDICAL CORP. | 34322 | 53309897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |