FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3973675
·
Received August 1, 2014
Report
- Report Number
- 9616091-2014-01395
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Report Date
- July 1, 2014
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER SAID THE USER SAID SHE WAS AT (B)(6) AND LOST ABOUT 30 LBS. HE SEES THE LT SIDE FRAME LEANING IN BECAUSE THE SEAT GUIDES ARE STRETCHED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449706 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | TREX20R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |