FDA Adverse Event
Malfunction
Summary report: N
TRACER TRANSPORT CHAIR 17 X 16 9153647024
MDR report key: 4959901
·
Received August 3, 2015
Report
- Report Number
- 9616091-2015-01982
- Event Type
- Malfunction
- Date Received
- August 3, 2015
- Date of Event
- December 1, 2014
- Report Date
- July 9, 2015
- 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). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DEALER STATES ON (B)(6) 2014 END USER STATED THE LEFT WHEEL LOCK WAS NOT HOLDING. DEALER STATED IT WAS BENT AND REPLACED THE LEFT WHEEL LOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505225 | TRACER TRANSPORT CHAIR 17 X 16 9153647024 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | TRSX5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |