FDA Adverse Event
Injury
Summary report: N
BARD
MDR report key: 105469
·
Received June 30, 1997
Report
- Report Number
- 105469
- Event Type
- Injury
- Date Received
- June 30, 1997
- Date of Event
- January 7, 1997
- Report Date
- January 14, 1997
- Manufacturer
- C.R. BARD, INC. BARD UROLOGICAL DIVISION
- Product Code
- KOD
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FOLEY CATHETER WAS PLACED. BALLOON WAS INFLATED AT DISTAL END OF URETHRA VS BLADDER. REQUIRED PT TO RETURN TO SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD | FOLEY CATHETER | KOD | C.R. BARD, INC. BARD UROLOGICAL DIVISION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |