FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 813648
·
Received January 17, 2007
Report
- Report Number
- 1418479-2007-00001
- Event Type
- Injury
- Date Received
- January 17, 2007
- Report Date
- January 17, 2007
- Manufacturer
- *
- Product Code
- FFZ
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED DUE TO END USER CANNOT DETERMINE WHICH CORD WAS INVOLVED IN THE INCIDENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE PHYSICIAN HANDED THE SCOPE TO THE SCRUB TECH AND ASKED FOR THE LIGHT TO BE TURNED OFF. THE LIGHT CORD WAS PUT DOWN ON THE DRAPE. MOMENTS LATER A BLACK HOLE IN THE DRAPE WAS NOTICED. THE DRAPE WAS REMOVED AND THE PT WAS FOUND TO HAVE A BURN ON THE LOWER LIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | FFZ | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |