MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-04-13 for DEMO 2 CROSSFIRE T7A UNKNOWN manufactured by Unknown.
[5717611]
The frame by the extension tube, the units frame is bent out of shape and will not hold the footrest in place. End user was sliding out and caused them to be bent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-02423 |
| MDR Report Key | 4685197 |
| Report Source | 08 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-02 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer City | OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEMO 2 CROSSFIRE T7A |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | KIC |
| Date Received | 2015-04-13 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-13 |