MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for SEAT GV/SB/VW20/VD20/VAH 9153648882 UNKNOWN manufactured by Unknown.
[26845952]
Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[26845953]
Provider states that the right easy mount bracket broke while the patient was in the chair. Per provider, the wheelchair is made by quickie and has an invacare back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-04625 |
| MDR Report Key | 5099805 |
| Date Received | 2015-09-24 |
| Date of Report | 2015-08-26 |
| Date Mfgr Received | 2015-08-26 |
| Date Added to Maude | 2015-09-24 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 0 |
| Brand Name | SEAT GV/SB/VW20/VD20/VAH 9153648882 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2015-09-24 |
| 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 | 2015-09-24 |