FDA Adverse Event
Injury
Summary report: N
EXACT COUCH
MDR report key: 610994
·
Received June 3, 2005
Report
- Report Number
- 2914292-2005-00006
- Event Type
- Injury
- Date Received
- June 3, 2005
- Date of Event
- May 2, 2005
- Report Date
- June 2, 2005
- Manufacturer
- VARIAN MEDICAL SYSTEMS, INC.
- Product Code
- LGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD COMPLETED TREATMENT, AND WAS BEING LOWERED WHILE ON THE TREATMENT COUCH. THE PT LOWERED THEIR HANDS TO A POSITION WHICH WAS UNDER THE COUCH TOP SLIDING RAILS, WHILE THE COUCH WAS SIMULTANEOUSLY BEING MOVED OUT LONGITUDINALLY. THEIR FINGER BECAME TRAPPED/PINCHED BETWEEN THE TOP SLIDING RAIL AND THE PEDESTAL BASE. HE PT WAS TAKEN OFF THE TABLE, EVALUATED BY A NURSE, AND SUBSEQUENTLY TAKEN TO THE EMERGENCY DEPT. PT WAS DIAGNOSED WITH A FRACTURE OF THE 3RD DIGIT, REQUIRING "SPLINTING" OF THE FINGER. THE PT WAS NOT HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXACT COUCH | PT POSITIONING TABLE | LGX | VARIAN MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |