MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-12-19 for INVACARE MATRX PS CUSHION W20 X D18 9153650831 UNKNOWN manufactured by Unknown.
[5180220]
It was reported by dealer that the end user has a matrx pb back from a few years ago and he doesn't have order or s/n info for the chair. He stated that the right bracket on the bottom is unattached and is hanging because it has broken off. He advised her not to use the back any longer and it has not caused any injury. He believes it is the quick release hardware and he sent a picture but was advised that we could not confirm the back hardware in the picture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2014-08774 |
| MDR Report Key | 4346873 |
| Report Source | 08 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-01 |
| Date Mfgr Received | 2014-12-01 |
| Date Added to Maude | 2015-01-06 |
| 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 | KAREN LOUGHREN |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| 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 | INVACARE MATRX PS CUSHION W20 X D18 9153650831 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2014-12-19 |
| 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 | 2014-12-19 |