FDA Adverse Event
Malfunction
Summary report: N
UTS¿
MDR report key: 1823092
·
Received August 11, 2010
Report
- Report Number
- 1823092
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- July 4, 2010
- Report Date
- August 11, 2010
- Manufacturer
- COOK MEDICAL
- Product Code
- KNS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE WIRE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UTS¿ | SPHINCTEROTOME | KNS | COOK MEDICAL | * | G22429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |