FDA Adverse Event
Injury
Summary report: N
RETRACTOR WITH FAN BLADE
MDR report key: 22243
·
Received May 15, 1995
Report
- Report Number
- 22243
- Event Type
- Injury
- Date Received
- May 15, 1995
- Date of Event
- April 6, 1995
- Report Date
- May 15, 1995
- Manufacturer
- ELMED, INC.
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
A BLADE ON A FAN RETRACTOR BROKE OFF IN PT DURING SURGERY. BLADE WAS REMOVED IN SURGERY AT A DIFFERENT INSTITUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RETRACTOR WITH FAN BLADE | RETRACTOR WITH FAN BLADE | GAD | ELMED, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization |