FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 3940729
·
Received July 2, 2014
Report
- Report Number
- 2438477-2014-00006
- Event Type
- Injury
- Date Received
- July 2, 2014
- Report Date
- June 6, 2014
- Manufacturer
- WU'S TECH CO. LTD.
- Product Code
- INI
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DRIVE MEDICAL HAS RECEIVED A PATIENT COMPLAINT ABOUT AN INCIDENT INVOLVING A 3 WHEEL SCOOTER IMPORTED AND DISTRIBUTED BY DRIVE MEDICAL. THE CLAIMANT ALLEGED THAT SCOOTER'S HAND CONTROL WENT TOO FAST CAUSING HER TO FALL AND ALLEGEDLY BREAK 10 RIBS. DETAILS OF THE INCIDENT AND PRODUCT PROBLEM IS UNKNOWN. THIS MDR REPORT IS BASED ON THE INFORMATION PROVIDED BY THE DME DEALER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385315 | DRIVE MEDICAL | VEHICLE, MOTORIZED 3-WHEELED | INI | WU'S TECH CO. LTD. | PHOENIXHD3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |