FDA Adverse Event
Malfunction
Summary report: N
INNOVATIVE PRODUCTS UNLIMITED, INC.
MDR report key: 1507351
·
Received September 25, 2009
Report
- Report Number
- 1833497-2009-00003
- Event Type
- Malfunction
- Date Received
- September 25, 2009
- Date of Event
- September 8, 2009
- Report Date
- September 23, 2009
- Manufacturer
- INNOVATIVE PRODUCTS UNLIMITED, INC.
- Product Code
- INN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESIDENT WAS BEING WHEELED TO THE SHOWER WHEN THE CHAIR BROKE CAUSING THE RESIDENT TO FALL TO THE GROUND. MAINT. DIRECTOR NOTICED A CRACK IN THE CHAIR. SHOWER CHAIR WAS OVER 9 YEARS OLD, SENT CUSTOMER NEW CHAIR TO REPLACE THE BROKEN CHAIR. CHAIR WAS RETURNED AND INSPECTED. FOUND TO HAVE INCURRED HEAVY USAGE, WHEELS WERE IN POOR CONDITION WHICH COULD HAVE CAUSE UNDO STRESS WHEN GOING OVER THRESH HOLDS. NO FURTHER ACTION REQUIRED.
Description of Event or Problem · 1
RESIDENT WAS BEING WHEELED TO THE SHOWER BY THE CNA ON A SHOWER CHAIR WHEN THE CHAIR BROKE MAINT. DIRECTOR NOTICED A CRACK IN THE CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVATIVE PRODUCTS UNLIMITED, INC. | SHOWER CHAIR | INN | INNOVATIVE PRODUCTS UNLIMITED, INC. | SCC200 OS FS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |