FDA Adverse Event
Malfunction
Summary report: N
INNOVATIVE PRODUCTS UNLIMITED, INC.
MDR report key: 1651128
·
Received March 31, 2010
Report
- Report Number
- 1833497-2010-00005
- Event Type
- Malfunction
- Date Received
- March 31, 2010
- Date of Event
- March 10, 2010
- Report Date
- March 30, 2010
- Manufacturer
- INNOVATIVE PRODUCTS UNLIMITED, INC.
- Product Code
- INN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESIDENT WAS IN SHOWER CHAIR GOING OVER A THRESHOLD WHEN THE RIGHT FRONT CASTER BROKE CAUSING HER TO FALL FORWARD RESULTING IN A FRACTURED FEMUR. CHAIR WAS NOT RETURNED FOR OBSERVATION AND WE WERE UNABLE TO OBTAIN VERY MUCH INFORMATION. NO FURTHER ACTION REQUIRED AT THIS TIME.
Description of Event or Problem · 1
RESIDENT WAS IN SHOWER CHAIR GOING OVER A THRESHOLD WHEN THE RIGHT FRONT CASTER BROKE CAUSING HER TO FALL TOWARD RESULTING IN A FRACTURED FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVATIVE PRODUCTS UNLIMITED, INC. | SHOWER CHAIR | INN | INNOVATIVE PRODUCTS UNLIMITED, INC. | SCC9250 OS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |