FDA Adverse Event
Injury
Summary report: N
STAMEY PERCUTANEOUS SUPRAPUBIC CATHETER
MDR report key: 16323
·
Received February 17, 1994
Report
- Report Number
- 16323
- Event Type
- Injury
- Date Received
- February 17, 1994
- Date of Event
- October 20, 1993
- Report Date
- October 22, 1993
- Manufacturer
- COOK UROLOGICAL
- Product Code
- FEW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CYSTOSCOPY FOR REMOVAL OF FRAGMENT OF SUPRAPUBLIC CATHETER FROM BLADDER. CATHETER TIP BROKE OFF WHILE PHYSICIAN REMOVING CATHETER DURING OFFICE VISIT OF 10/15/93.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAMEY PERCUTANEOUS SUPRAPUBIC CATHETER | 14 FR MALECOT CATHETER | FEW | COOK UROLOGICAL | UNKNOWN | 115947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |