FDA Adverse Event
Other
Summary report: N
LITE LIFT HOSPITAL CPM
MDR report key: 111883
·
Received July 3, 1997
Report
- Report Number
- 111883
- Event Type
- Other
- Date Received
- July 3, 1997
- Date of Event
- February 8, 1997
- Report Date
- March 19, 1997
- Manufacturer
- SUTTER CORP.
- Product Code
- BXB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT DEVELOPED FRICTION RUB TO CALF AFTER USING CPM MACHINE. PT STATUS POST KNEE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LITE LIFT HOSPITAL CPM | CPM MACHINE | BXB | SUTTER CORP. | CPM 7000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |