MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for INVACARE MATRX FLOVAIR MAX CONTOUR 18 IN X 18 IN 9153653328 ITFM88 manufactured by Invacare Taylor Street.
[44722248]
Mdr is being submitted as a result of a retrospective complaint review. Per the expanded evaluation observations sheet, the reported issue was not able to be confirmed. The gel pad had no damage and the gel did not appear to be accumulating in specific areas.
Patient Sequence No: 1, Text Type: N, H10
[44722249]
Territory business manager called and advised that the gel is migrating to the back of the cushion which caused a sore under the coccyx.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2016-01199 |
| MDR Report Key | 5627004 |
| Date Received | 2016-05-03 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-30 |
| Date Mfgr Received | 2014-05-01 |
| Date Added to Maude | 2016-05-03 |
| 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 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INVACARE MATRX FLOVAIR MAX CONTOUR 18 IN X 18 IN 9153653328 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2014-08-12 |
| Model Number | ITFM88 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |