FDA Adverse Event
Malfunction
Summary report: N
BARD
MDR report key: 3788339
·
Received April 28, 2014
Report
- Report Number
- MW5035870
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- February 18, 2014
- Report Date
- April 25, 2014
- Manufacturer
- BARD
- Product Code
- EXR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FOLEY WAS PLACED IN PT INTACT. AT 1300 WIFE COMPLAINED THAT FOLEY WAS LEAKING. CHECKED BALLOON APPEARED BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253382 | BARD | URINE METER FOLEY | EXR | BARD | NGXJ4043 | 902916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |