FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER NEW 8
MDR report key: 2993111
·
Received March 1, 2013
Report
- Report Number
- 9615050-2013-00302
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- January 30, 2013
- Report Date
- February 6, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301932 | PLUM A+ DRIVER NEW 8 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |