FDA Adverse Event
Malfunction
Summary report: N
COMPANION II
MDR report key: 5305661
·
Received September 11, 2004
Report
- Report Number
- 2523955-2004-00001
- Event Type
- Malfunction
- Date Received
- September 11, 2004
- Date of Event
- March 26, 2004
- Report Date
- September 8, 2004
- Manufacturer
- GOLDEN TECHNOLOGIES, INC.
- Product Code
- INI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
PATIENT WAS ALLEGEDLY THROWN FROM SCOOTER DOWN A 15' CLIFF. PATIENT'S WIFE (REPORTER) SAYS THAT THE PATIENT HAD A CONCUSSION, FACIAL LACERATIONS AND A BACK INJURY AS A RESULT OF FALLING. REPORTER ALLEGES THAT THE SCOOTER SURGED CAUSING THE ACCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPANION II | 3-WHEELED SCOOTER | INI | GOLDEN TECHNOLOGIES, INC. | GC321 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |