FDA Adverse Event
Injury
Summary report: N
ONE TOUCH ULTRA METER
MDR report key: 1032809
·
Received April 21, 2008
Report
- Report Number
- 2939301-2008-00607
- Event Type
- Injury
- Date Received
- April 21, 2008
- Report Date
- April 4, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | 2538549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| L| R |