FDA Adverse Event
Injury
Summary report: N
INVACARE CORPORATION/BATH SUPPORT PRODUCTS
MDR report key: 880529
·
Received July 13, 2007
Report
- Report Number
- 1525712-2007-00039
- Event Type
- Injury
- Date Received
- July 13, 2007
- Date of Event
- July 17, 2006
- Report Date
- July 2, 2007
- Manufacturer
- INVACARE CORP. - PT AIDS MFG
- Product Code
- INM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
NO MALFUNCTION ALLEGED. CONSUMER WAS INSTRUCTED ON PROPER USE. DEALER SUPPLIED CONSUMER WITH ACCESSORIES TO AID THEM IN SUPPORT. THE CHAIR REMAINS IN USE.
Description of Event or Problem · 1
THE CONSUMER'S WIFE WAS ASSISTING HIM IN THE SHOWER. THE PUSHED HIM FORWARD TO WASH HIS BACK AND HIS WEIGHT DISTRIBUTED ONTO ONE OF THE FRONT RIGGINGS, ALLEGEDLY CAUSING THE CHAIR TO TIP, CAUSING HIM TO FALL OUT AND BREAK HIS FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE CORPORATION/BATH SUPPORT PRODUCTS | 890.3100 | INM | INVACARE CORP. - PT AIDS MFG | UNKSHCH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |