FDA Adverse Event
Summary report: N
WHEELCHAIR COMPONENTS
MDR report key: 4223040
·
Received November 4, 2014
Report
- Report Number
- 1531186-2014-05339
- Date Received
- November 4, 2014
- Report Date
- October 15, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER STATED BOTH FOOTPLATE WERE CRACKED BY THE END USER. THE DEALER STATED HE DID NOT BELIEVE THIS WAS A MANUFACTURING DEFECT. THE DEALER DID NOT PROVIDE THE SERIAL NUMBER, SO WE ARE UNABLE TO VERIFY THE CHAIR MODEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707951 | WHEELCHAIR COMPONENTS | 890.3920 | IOR | UNKNOWN | T94HC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |