FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 3020235
·
Received March 25, 2013
Report
- Report Number
- 1531186-2013-01275
- Date Received
- March 25, 2013
- Report Date
- February 28, 2013
- Manufacturer
- C.T.M. HOMECARE PRODUCT, INC
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES BRAKE IS NOT WORKING. NO SERIAL NUMBER PROVIDED. PART NUMBER, (B)(4), IS FOR EITHER A LYNX 3 OR 4 TRANSAXLE. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122053 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | C.T.M. HOMECARE PRODUCT, INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |