FDA Adverse Event
Injury
Summary report: N
WIRE
MDR report key: 2814715
·
Received October 5, 2012
Report
- Report Number
- 2520274-2012-02165
- Event Type
- Injury
- Date Received
- October 5, 2012
- Report Date
- September 6, 2012
- Product Code
- DZK
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRE | WIRE | DZK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCREWS| WIRES |