FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2919268
·
Received January 16, 2013
Report
- Report Number
- 9616091-2013-00091
- Event Type
- Malfunction
- Date Received
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER STATES CHROME IS PEELING OFF. IN SPEAKING WITH REPORTER IT WAS LEARNED THE END USER WAS USING THE CHAIR AND SUSTAINED A CUT ON THEIR FINGER DUE TO THE PEELING OF THE CHROME. MELISSA STATED THAT THE MAINTENANCE PERSON LOOKING AT THE CHAIR ALSO SUSTAINED A CUT ON HIS HAND. THE CHAIR IS AWAITING REPLACEMENT. NO INFORMATION SUGGESTS MEDICAL INTERVENTION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24322 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | TRSX5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |