FDA Adverse Event
Malfunction
Summary report: N
INNOVATIVE PRODUCTS UNLIMITED, INC.
MDR report key: 4009408
·
Received July 11, 2014
Report
- Report Number
- 1833497-2014-00016
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Date of Event
- June 26, 2014
- Report Date
- July 10, 2014
- Manufacturer
- INNOVATIVE PRODUCTS UNLIMITED, INC.
- Product Code
- INM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE TWO CASTERS ON THE FRONT OF THE CHAIR WERE REPLACED WITH CASTERS THAT WERE NOT THE SAME AS THE ORIGINAL CASTERS. THE CASTERS IN THE FRONT WERE NOT THE SAME HEIGHT AS THE CASTERS IN THE BACK CAUSING STRESS ON THE PIPES BECAUSE THEY WERE NOT LINED UP CORRECTLY. THE FRONT TO BACK PIPE CAME LOOSE CAUSING THE T BELOW THE SEAT TO BREAK.
Description of Event or Problem · 1
PT WAS SITTING ON THE SHOWER CHAIR WHEN THE LEFT SIDE BROKE AT THE T FITTING LOCATED JUST UNDER THE SEAT. ALSO, THE LOWER SUPPORT PIPE GOING FROM THE REAR LEFT CASTER TO THE FRONT LEFT CASTER BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406815 | INNOVATIVE PRODUCTS UNLIMITED, INC. | SHOWER CHAIR | INM | INNOVATIVE PRODUCTS UNLIMITED, INC. | SC200 OS FS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |