FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3103391
·
Received May 9, 2013
Report
- Report Number
- 1525712-2013-03648
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Report Date
- April 15, 2013
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INDICTING THE MANUFACTURER AND SERIAL NUMBER AS UNKNOWN. THE SERIAL NUMBER PROVIDED IS INVALID IN INVACARES SERIAL NUMBER TRACKING SYSTEM. BASED ON THE ORDER NUMBER THE (B)(4) IN THE NUMBER IS CORRECT, THUS INDICATING THAT INVAMEX IS THE MANUFACTURER. (B)(4).
Description of Event or Problem · 1
DEALER STATES THE THE WHEEL IS WOBBLY AND WARPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204296 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | INVAMEX | TRSX5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |