FDA Adverse Event
Injury
Summary report: N
COMMODE
MDR report key: 71010
·
Received February 19, 1997
Report
- Report Number
- 1525712-1997-00009
- Event Type
- Injury
- Date Received
- February 19, 1997
- Report Date
- February 11, 1997
- Manufacturer
- INVACARE CORP.
- Product Code
- IKW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
LETTER FROM A USER REPORTED THAT A TOILET SEAT SHIFTED WHEN THE PT ATTEMPTED TO GET UP. THIS ALLEGEDLY CAUSED HER TO FALL AND REINJURE HER BACK. ATTEMPTS TO EVALUATE THE DEVICE OR OTHERWISE GATHER MORE INFO HAVE THUS FAR BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMMODE | DAILY ACTIVITY ASSIST DEVICE | IKW | INVACARE CORP. | RAISED TOILET SEAT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |