FDA Adverse Event
Other
Summary report: N
ONE TOUCH ULTRA
MDR report key: 904006
·
Received August 26, 2004
Report
- Report Number
- 2939301-2004-04666
- Event Type
- Other
- Date Received
- August 26, 2004
- Report Date
- August 25, 2004
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | 2519902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |