FDA Adverse Event
Other
Summary report: N
CPM - MODEL #2030
MDR report key: 300226
·
Received October 12, 2000
Report
- Report Number
- 300226
- Event Type
- Other
- Date Received
- October 12, 2000
- Date of Event
- October 9, 2000
- Report Date
- October 12, 2000
- Manufacturer
- CHATTANOOGA GROUP, INC.
- Product Code
- BXB
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT BACK FROM OR APPROX 1300. PROCEDURE LEFT TOTAL KNEE. CONTINUOUS PASSIVE MOTION MACHINE PLACED UNDER LEFT LEG AND APPLIED CORRECTLY. PT KEPT PUTTING RIGHT FOOT IN BETWEEN CPM MACHINE ROTATING AREA. THIS CAUSED A LACERATION BETWEEN RIGHT GREAT TOE AND 2ND TOE. 9 STITCHES REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CPM - MODEL #2030 | CPM | BXB | CHATTANOOGA GROUP, INC. | 2030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |