FDA Adverse Event
Malfunction
Summary report: N
OPERA PPP
MDR report key: 397571
·
Received May 31, 2002
Report
- Report Number
- 9617021-2002-00089
- Event Type
- Malfunction
- Date Received
- May 31, 2002
- Date of Event
- April 10, 2002
- Report Date
- April 25, 2002
- Manufacturer
- ARJO LTD.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTS THE RESIDENT WAS NORMALLY BEING LIFTED IN A LARGE SLING. THE RESIDENT HAD LOST WEIGHT AND WAS NOT BEING LIFTED IN A MEDIUM SLING. THE RESIDENT FELL OUT OF THE SLING AND INTO THE BATH. NO INJURIES WERE SUSTAINED TO THE CLIENT.
Description of Event or Problem · 1
THE FACILITY REPORTS THE RESIDENT WAS NORMALLY BEING LIFTED IN A LARGE SLING. THE RESIDENT HAD LOST WEIGHT AND WAS NOT BEING LIFTED IN A MEDIUM SLING. THE RESIDENT FELL OUT OF THE SLING AND INTO THE BATH. NO INJURIES WERE SUSTAINED TO THE CLIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERA PPP | PATIENT LIFT | FSA | ARJO LTD. | KPBXXXX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |