FDA Adverse Event
Summary report: N
BARDEX ALL-SILICONE FOLEY CATHETER
MDR report key: 1011242
·
Received February 26, 2008
Report
- Report Number
- 1011242
- Date Received
- February 26, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 2008
- Manufacturer
- BARD UROLOGICAL DIVISION
- Product Code
- KOD
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN WAS PULLING PLUNGER OF SYRINGE TO DEFLATE BALLOON OF CATHETER. AS THE CATHETER WAS WITHDRAWN PATIENT COMPLAINED OF PAIN AND THERE WAS RESISTANCE OF THE CATHETER. AFTER REMOVAL PHYSICIAN LOOKED AT BALLOON AND NOTED BALLOON WAS "WRINKLED." PATIENT VOIDED AFTER REMOVAL WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARDEX ALL-SILICONE FOLEY CATHETER | CATHETER, FOLEY | KOD | BARD UROLOGICAL DIVISION | * | NGRH3402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |