FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 3255126
·
Received July 30, 2013
Report
- Report Number
- 1531186-2013-03496
- Date Received
- July 30, 2013
- Report Date
- July 15, 2013
- Manufacturer
- C.T.M. HOMECARE PRODUCT, INC
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 1531186-2013-03496, INDICTING THE MANUFACTURER AS CHIEN TI ENTERPRISE CO., LTD. THE CORRECT MANUFACTURER IS C.T.M. HOMECARE PRODUCTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A L-3B SCOOTER HAD AN UNKNOWN MALFUNCTION. IT WAS UNSPECIFIED WHETHER THERE WAS INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356343 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | C.T.M. HOMECARE PRODUCT, INC | L-3B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |