FDA Adverse Event
Injury
Summary report: N
SUTURE WIRE/LRN
MDR report key: 1413800
·
Received July 14, 2009
Report
- Report Number
- 1020279-2009-00622
- Event Type
- Injury
- Date Received
- July 14, 2009
- Date of Event
- June 24, 2009
- Report Date
- July 14, 2009
- Manufacturer
- BROOKS MANUFACTURING SITE
- Product Code
- LRN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE WIRE BROKE AND HAD TO BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUTURE WIRE/LRN | LRN | BROOKS MANUFACTURING SITE | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization| R |