FDA Adverse Event
Injury
Summary report: N
9617604-2008-00097
MDR report key: 1110986
·
Received August 4, 2008
Report
- Report Number
- 9617604-2008-00097
- Event Type
- Injury
- Date Received
- August 4, 2008
- Product Code
- BSY
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
RESULTS EVALS: SMITHS MEDICAL IS STILL TRYING TO OBTAIN FURTHER INFO FROM THE USER FACILITY. TO DATE WE CAN REPORT THAT WE HAVE NO OTHER REPORTS ON TWO POSSIBLE LOTS PROVIDED. NO SAMPLES HAVE BEEN RETURNED. NO OTHER FACILITY EXPERIENCING ANY DIFFICULTIES. IF WE ARE ABLE TO OBTAIN FURTER INFO, OR SAMPLES, THAEN A F/U REPORT WILL BE SUBMITTED. IF NO FURTHER INFO PROVIDED, THEN THIS WILL BE AN UNCONFIRMED REPORT AND UNABLE TO DETERMINE IF RELATED TO DEVICE OR USER INTERFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BSY | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |