FDA Adverse Event
Injury
Summary report: N
TEMPO PPP
MDR report key: 540150
·
Received August 23, 2004
Report
- Report Number
- 9617021-2004-00082
- Event Type
- Injury
- Date Received
- August 23, 2004
- Date of Event
- June 7, 2004
- Report Date
- July 13, 2004
- Manufacturer
- ARJO MED AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT WAS BEING TRANSFERRED FROM THE BED TO THE WHEELCHAIR WHEN THE LEG STRAPS RELEASED AND THE PT FELL TO THE FLOOR. THE RESIDENT SUFFERED A HEAD LACERATION AND A SKIN TEAR TO THE RIGHT ELBOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPO PPP | PATIENT LIFT | FSA | ARJO MED AB LTD. | KPBXXXX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |