FDA Adverse Event
Injury
Summary report: N
MEDULLARY TUBE
MDR report key: 111764
·
Received August 6, 1997
Report
- Report Number
- 2520274-1997-00011
- Event Type
- Injury
- Date Received
- August 6, 1997
- Manufacturer
- *
- Product Code
- FZX
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
DISCLAIMER: SYNTHES (USA) IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED UPON INFO WHICH SYNTHES (USA) HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES (USA) OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11. CORRECTED DATA. H3,H6 - ACTUAL DEVICE WAS EVALUATED. A VISUAL EXAMINATION WAS PERFORMED, HOWEVER DUE TO THE CONDITION OF THE DEVICE AN ACCURATE EVALUATION COULD NOT BE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDULLARY TUBE | * | FZX | * | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |