FDA Adverse Event
Summary report: N
*
MDR report key: 1131363
·
Received August 11, 2008
Report
- Report Number
- 1131363
- Date Received
- August 11, 2008
- Date of Event
- July 22, 2008
- Report Date
- August 11, 2008
- Manufacturer
- DEROYAL INDUSTRIES
- Product Code
- FSY
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE DISPOSABLE LIGHT HANDLE FELL FROM THE LIGHT ONTO THE STERILE FIELD AT SITE OF THE SURGICAL INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | HANDLE, SURGICAL LIGHT | FSY | DEROYAL INDUSTRIES | 26-012 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |