FDA Adverse Event
Other
Summary report: N
INPECO SYSTEM
MDR report key: 927838
·
Received October 16, 2007
Report
- Report Number
- 1628664-2007-00453
- Event Type
- Other
- Date Received
- October 16, 2007
- Report Date
- September 21, 2007
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JQW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROCESS, NO CODES CAN BE DETERMINED AT THIS TIME. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE OPERATOR RECEIVED A CUT BETWEEN THE THUMB AND THE PALM OF HER HAND FROM A METAL BRACKET NEAR THE DECAPPER ON THE INPECO SYSTEM WHEN REMOVING SAMPLES FROM THE TRACK AREA. THE OPERATOR WASHED HER HAND AND PUT A BAND-AID ON THE CUT. NO FURTHER MEDICAL TREATMENT WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INPECO SYSTEM | AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM | JQW | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |