FDA Adverse Event
Malfunction
Summary report: N
T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569
MDR report key: 5004335
·
Received August 14, 2015
Report
- Report Number
- 9616091-2015-02065
- Event Type
- Malfunction
- Date Received
- August 14, 2015
- Report Date
- July 22, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
END USER STATES, THE RIGHT FRAME IS BENT .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537851 | T4/WD28/HD/ADULT/18/BH16/AT903/U2222C/U67 9153653569 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | T422RDA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |