FDA Adverse Event
Malfunction
Summary report: N
TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
MDR report key: 4356801
·
Received December 23, 2014
Report
- Report Number
- 1525712-2014-08874
- Event Type
- Malfunction
- Date Received
- December 23, 2014
- Report Date
- December 3, 2014
- Manufacturer
- UNKNOWN
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE CALLER STATES THAT THE LEFT REAR SEAT GUIDE ON THE CHAIR IS BROKEN. THE CALLER WAS UNABLE TO READ THE SERIAL NUMBER ON THE CHAIR BECAUSE IT WAS RUBBED OFF. WE DETERMINED THAT THE CHAIR WAS A TRACER EX. I GAVE HIM A PART NUMBER FOR THE SEAT GUIDE (#1023617). HE WILL GIVE IT TO HIS MAINTENANCE MAN WHO WILL ORDER THE PART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847731 | TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553 | WHEELCHAIR, MECHANICAL | IOR | UNKNOWN | TREX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |