FDA Adverse Event
Summary report: N
BREAST RETRACTOR WITH FIBER OPTIC
MDR report key: 2438790
·
Received January 18, 2012
Report
- Report Number
- 2438790
- Date Received
- January 18, 2012
- Date of Event
- December 14, 2011
- Report Date
- January 18, 2012
- Manufacturer
- ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. (ASSI)
- Product Code
- GAD
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE LIGHTED BREAST RETRACTOR WAS BEING USED DURING A PROCEDURE WHEN THE SURGEON NOTICED THE PATIENT HAD A SMALL BURN. IT IS UNKNOWN WHEN OR IF THE BREAST RETRACTOR WAS PLACED ON THE PATIENT WHILE THE LIGHT WAS ON. THE PATIENT WAS SEEN A WEEK AFTER THE PROCEDURE AND WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREAST RETRACTOR WITH FIBER OPTIC | LIGHT BREAST RETRACTOR | GAD | ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. (ASSI) | ABR 29326 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |