FDA Adverse Event
Other
Summary report: N
LUGGIE SCOOTER
MDR report key: 3267273
·
Received July 26, 2013
Report
- Report Number
- 3003820676-2013-00002
- Event Type
- Other
- Date Received
- July 26, 2013
- Manufacturer
- FREERIDER, CORP.
- Product Code
- KNL
- PMA / PMN Number
- K110165
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE USER HAS NOT RETURNED THE LUGGIE SCOOTER TO THE DEALER NOR THE IMPORTER FOR FURTHER EVALUATION. WE'RE NOT ABLE TO GET TO KNOW THE SCOOTER'S CONDITION AT THIS STAGE. AFTER RECEIVING THE SCOOTER'S SERIAL NUMBER FROM THE IMPORTER, WE'LL CONDUCT THE RELEVANT TESTS.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349645 | LUGGIE SCOOTER | LUGGIE SCOOTER | KNL | FREERIDER, CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |