FDA Adverse Event
Other
Summary report: N
FAN RETRACTOR
MDR report key: 273965
·
Received April 14, 2000
Report
- Report Number
- 1038548-2000-00004
- Event Type
- Other
- Date Received
- April 14, 2000
- Date of Event
- January 31, 2000
- Report Date
- February 23, 2000
- Manufacturer
- GENZYME SURGICAL PRODUCTS CORP.
- Product Code
- GAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FOLLOWING A THORACOTOMY PROCEDURE, THE PT WAS GIVEN A FOLLOW-UP CHEST X-RAY TO ENSURE PROCEDURE WENT WELL. UPON REVIEW OF THE FILMS, THE DR ALLEGES THAT A PIECE OF THE FAN RETRACTOR USED DURING THE PROCEDURE WAS IDENTIFIED INSIDE THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAN RETRACTOR | RETRACTOR | GAD | GENZYME SURGICAL PRODUCTS CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |