FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 621655
·
Received June 29, 2005
Report
- Report Number
- 621655
- Event Type
- Malfunction
- Date Received
- June 29, 2005
- Date of Event
- June 25, 2005
- Report Date
- June 29, 2005
- Manufacturer
- INVACARE CORPORATION
- Product Code
- ILZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
THE PATIENT INVOLVED IS A HOMECARE PATIENT. THE EQUIPMENT INVOLVED WAS RENTED BY THE PATIENT FROM AN OUTSIDE VENDOR. THE PATIENT WAS BEING HELPED INTO BED BY A FAMILY MEMBER. THE PATIENT WAS USING THE BED TRAPEZE. THE BED TRAPEZE BROKE AND THE PATIENT FELL DOWN ON THE BED RAIL ON THE RIGHT HIP. HOMECARE PERSONNEL CONTACT FACILITY, BUT THE VENDOR DECLINED TO PROVIDE THE MODEL NUMBER OR MANUFACTURER OF THE TRAPEZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | BED TRAPEZE | ILZ | INVACARE CORPORATION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |