FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 3031662
·
Received April 2, 2013
Report
- Report Number
- 1531186-2013-01370
- Date Received
- April 2, 2013
- Report Date
- March 6, 2013
- Manufacturer
- C.T.M. HOMECARE PRODUCT, INC
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER STATES THE STEERING COLUMN LOCKS INTO PLACE AND THE SCOOTER VEERS MORE LEFT. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134975 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | C.T.M. HOMECARE PRODUCT, INC | L-3R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |