FDA Adverse Event
Injury
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2915837
·
Received January 15, 2013
Report
- Report Number
- 1525712-2013-00365
- Event Type
- Injury
- Date Received
- January 15, 2013
- Date of Event
- December 13, 2012
- Report Date
- January 14, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ITI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PLEASE NOTE: EVENT IS BEING FILED AS A SERIOUS INJURY SINCE THE PARAMEDICS LIKELY EVALUATED THIS END USER. NO FURTHER MEDICAL INTERVENTION WAS SOUGHT. ALSO, ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE SUPPLIED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
END USER WAS IN THIS CHAIR USING THE RAMP/LIFT TO GET OUT OF THE VAN AND THE POWERED WHEELCHAIR WAS NOTED TO TILT FORWARD A LITTLE. REPORTEDLY THE SEAT BELT BROKE AND USER FELL OUT OF IT. THE DEALER REPORTED THE GROMMET NEAR WHERE THE SEAT BELT ATTACHES TO THE CHAIR LET GO AND THE SEAT BELT FABRIC TORE. PATIENT FELL ONTO THE GROUND. PARAMEDICS WERE CALLED FOR ASSISTANCE. NO INJURY AND HE DID NOT GO TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22862 | POWERED WHEELCHAIR | 890.3860 | ITI | INVACARE TAYLOR STREET | TDXSP-MCG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |