FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 5353610
·
Received January 8, 2016
Report
- Report Number
- 1525712-2016-00056
- Event Type
- Malfunction
- Date Received
- January 8, 2016
- Report Date
- February 3, 2016
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: WHEELS, BEARING FAILURE. BEARING FAILURE: TIRE HAS SIGNS OF FLAT SPOTS RIM HAS BEEN CUT BY BEARINGS. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: WHEELS, BEARING FAILURE. BEARING FAILURE: TIRE HAS SIGNS OF FLAT SPOTS RIM HAS BEEN CUT BY BEARINGS. THE DEALER STATED THE BEARINGS SHATTERED, THE RIM LOOKS CRACKED AND THE TIRE IS CHOPPED.
Description of Event or Problem · 1
THE DEALER STATED THE BEARINGS SHATTERED, THE RIM LOOKS CRACKED AND THE TIRE IS CHOPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13996 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVACARE TAYLOR STREET | SOLARA3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |