FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 1074413
·
Received June 25, 2008
Report
- Report Number
- 1219611-2008-00003
- Event Type
- Injury
- Date Received
- June 25, 2008
- Manufacturer
- SMITHS MEDICAL BY MEDEX
- Product Code
- FOZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
EVAL: WE ARE ANTICIPATING OBTAINING DIGITAL PICTURES OF THE SAMPLE INVOLVED IN THIS EVENT. UPON THE RECEIPT OF THE PICTURES, AND THE COMPLETED INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. A REVIEW OF OUR COMPLAINTS DATABASE REVEALS NO OTHER REPORTS ON THIS DEVICE LOT NUMBER. A REVIEW OF SIMILAR FILES REVEALS THAT THIS IS LIKELY A TECHNIQUE ISSUE RELATED TO NOT FOLLOWING THE INSTRUCTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | 80-FOZ | FOZ | SMITHS MEDICAL BY MEDEX | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |