FDA Adverse Event
Malfunction
Summary report: N
POWERED WHEELCHAIR
MDR report key: 2981818
·
Received February 27, 2013
Report
- Report Number
- 1525712-2013-01499
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- February 1, 2013
- Manufacturer
- UNKNOWN
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER (B)(6), THE CONSUMER WAS VERY VAGUE OVER PHONE EXACTLY WHERE THE CROSS BRACES WERE CRACKED, HOW DEEP , LONG, ETC.. HE JUST KNOWS THEY ARE CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84516 | POWERED WHEELCHAIR | 890.3860 | ITI | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |