FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 2648375
·
Received July 10, 2012
Report
- Report Number
- 1531186-2012-00513
- Date Received
- July 10, 2012
- Report Date
- October 9, 2012
- Manufacturer
- C.T.M. HOMECARE PRODUCT, INC
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 #1531186-2012-00513 INDICATING THE MANUFACTURER AS CT MEDICAL, INC. THE CORRECT MANUFACTURER IS C.T.M. HOMECARE PRODUCTS.
Description of Event or Problem · 1
CUSTOMER ALLEGED THAT SCOOTER MADE A WHINING NOISE & STOPPED INTERMITTENTLY. (B)(4). NO INJURY ALLEGED.
Description of Event or Problem · 1
CUSTOMER ALLEGED THAT SCOOTER MADE A WHINING NOISE AND STOPPED INTERMITTENTLY. QUOTE #(B)(4). NO INJURY ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | C.T.M. HOMECARE PRODUCT, INC | L4R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |