FDA Adverse Event
Death
Summary report: N
DRIVE MEDICAL
MDR report key: 902314
·
Received August 24, 2007
Report
- Report Number
- 2438477-2007-00004
- Event Type
- Death
- Date Received
- August 24, 2007
- Date of Event
- July 20, 2006
- Report Date
- July 26, 2007
- Manufacturer
- MEDICAL DEPOT, INC. (D/B/A DRIVE MEDICAL DESIGN & MFG)
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADD'L INFO IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
USER WAS RIDING ON AND OPERATING THE SCOOTER ON THE SIDEWALK, AT WHICH POINT THE SCOOTER, ALLEGEDLY SPED UP, WITHOUT WARNING, CAUSING THE USER TO LOSE CONTROL, LEAVE THE SIDEWALK, TURN ONTO THE STREET, WHICH IS A SIX INCH DROP-OFF, AND CAUSING THE SCOOTER TO OVERTURN. AS A RESULT OF WHICH, THE USER WAS ALLEGEDLY THROWN FROM THE SCOOTER ONTO THE STREET CAUSING HER SEVERE PERSONAL INJURIES. THE USER WAS HOSPITALIZED AFTER THE INCIDENT, AND DECEASED AT A LATER TIME. CAUSE OF DEATH IS UNKNOWN TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | POWER SCOOTER, 4-WHEEL | INI | MEDICAL DEPOT, INC. (D/B/A DRIVE MEDICAL DESIGN & MFG) | ODYSSEY | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |