FDA Adverse Event
Malfunction
Summary report: N
INVACARE CARE GUARD SHOWER CHAIR WITH BACK
MDR report key: 2211301
·
Received August 11, 2011
Report
- Report Number
- 2211301
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- April 23, 2011
- Report Date
- August 11, 2011
- Manufacturer
- INVACARE
- Product Code
- INM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
A PATIENT WAS PLACED IN THE INVACARE CARE GUARD SHOWER CHAIR WITH BACK IN FRONT OF BATHROOM SINK TO CLEAN UP. THE PATIENT TURNED THE LIGHT ON AND WAS FOUND ON FLOOR UNHARMED. HE STATED HE ATTEMPTED TO MOVE HIS CHAIR BACK CAUSING THE SHOWER CHAIR LEG TO BEND AND BREAK CAUSING HIM TO FALL TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE CARE GUARD SHOWER CHAIR WITH BACK | SHOWER CHAIR | INM | INVACARE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | NO OTHER THERAPIES |