FDA Adverse Event
Death
Summary report: N
DRIVE MEDICAL
MDR report key: 1666433
·
Received April 20, 2010
Report
- Report Number
- 2438477-2010-00009
- Event Type
- Death
- Date Received
- April 20, 2010
- Date of Event
- December 7, 2009
- Report Date
- April 1, 2010
- Manufacturer
- WU'S TECH CO., LTD.
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
(B)(4) HAS RECEIVED AN ATTORNEY LETTER ALLEGING THE FOLLOWING INCIDENT: A PATIENT DROVE A POWER SCOOTER FROM HER CONDOMINIUM TO DELIVER A BAG OF TRASH TO THE TRASH ROOM IN THE SAME BUILDING. IT WAS REPORTED THAT THE PATIENT HAD A SEAT BELT ON AND WAS KEEPING THE TRASH BAG BETWEEN HER FEET ON THE SCOOTER. IT IS ALLEGED THAT WHILE IN THE TRASH ROOM THE SEATBACK OF THE SCOOTER BROKE ALLEGEDLY CAUSING THE PATIENT TO FALL BACKWARDS, STRIKING HER HEAD AND SUBSEQUENTLY DIE FROM ASPHYXIATION. THIS MDR REPORT IS BASED ON THE ATTORNEY LETTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | POWER SCOOTER | INI | WU'S TECH CO., LTD. | DAYTONA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death |