FDA Adverse Event
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 2901795
·
Received January 8, 2013
Report
- Report Number
- 1531186-2013-00099
- Date Received
- January 8, 2013
- Report Date
- January 7, 2013
- Manufacturer
- JUMAO MEDICAL EQUIPMENT
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATED REAR WHEEL COMPOSITE SPOKE CRACKED IN AREA CLOSER TO WHEEL HUB. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9710 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | JUMAO MEDICAL EQUIPMENT | TREX28R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |