FDA Adverse Event
Injury
Summary report: N
EASYTRAK WHISPER MS-J GUIDE WIRE
MDR report key: 848771
·
Received May 10, 2007
Report
- Report Number
- 2124215-2007-21565
- Event Type
- Injury
- Date Received
- May 10, 2007
- Date of Event
- January 31, 2007
- Report Date
- January 31, 2007
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- NIK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK WHISPER MS-J GUIDE WIRE | GUIDE WIRE | NIK | CARDIAC PACEMAKERS | 6738 | 6111152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |