FDA Adverse Event
Malfunction
Summary report: N
T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569
MDR report key: 4886424
·
Received July 2, 2015
Report
- Report Number
- 9616091-2015-01724
- Event Type
- Malfunction
- Date Received
- July 2, 2015
- Report Date
- June 5, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DEALER IS STATING THAT THE WHEEL LOCKS ARE BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432599 | T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | T4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |