FDA Adverse Event
Malfunction
Summary report: N
TRSX5/WD06/18FB/BH16/ADULT/U2222C/1228/U240 9153653561
MDR report key: 4372915
·
Received December 31, 2014
Report
- Report Number
- 9616091-2014-02456
- Event Type
- Malfunction
- Date Received
- December 31, 2014
- Report Date
- October 27, 2014
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES THEY RENT WHEELCHAIRS AND THIS CHAIR WAS GOING TO BE CLEANED AND TECH NOTICED THAT THE CROSSRACE WAS BENT. PROVIDER GAVE PART NUMBER 1110002 WANTED TO VERIFY THAT HE NEEDED THAT PART TO REPLACE AND REPAIR THE CHAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862902 | TRSX5/WD06/18FB/BH16/ADULT/U2222C/1228/U240 9153653561 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | TRSX5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |