FDA Adverse Event
Malfunction
Summary report: N
TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
MDR report key: 5328747
·
Received December 28, 2015
Report
- Report Number
- 9616091-2015-02963
- Event Type
- Malfunction
- Date Received
- December 28, 2015
- Report Date
- February 5, 2016
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Additional Manufacturer Narrative · 1
PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: STANDARD WHEELCHAIRS. ASSEMBLY/COMPONENT ISSUE, BOX DAMAGE. NEW WHEELS RETURNED OUT OF ROUND BENT HAND RIM. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.
Description of Event or Problem · 1
DEALER STATES THE REAR WHEELS ARE BENT. HE STATES IT LOOKS LIKE THE RIMS ARE WARPED.
Description of Event or Problem · 1
PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: STANDARD WHEELCHAIRS. ASSEMBLY/COMPONENT ISSUE, BOX DAMAGE. NEW WHEELS RETURNED OUT OF ROUND BENT HAND RIM. DEALER STATES THE REAR WHEELS ARE BENT. HE STATES IT LOOKS LIKE THE RIMS ARE WARPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852939 | TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | TREX20RP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |