MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-29 for INVACARE MATRX FLO-TECH 22X20 9153652318 FT2220 manufactured by Invacare Taylor Street.
[44526771]
Mdr is being submitted as a result of a retrospective complaint review.
Patient Sequence No: 1, Text Type: N, H10
[44526772]
Tbm stated that the fluid sacs burst inside the cushion leaking out. Tbm stated the end user alleged that when the liquid sacs busted the liquid spilled on the floor and the wheelchair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2016-01175 |
| MDR Report Key | 5620625 |
| Date Received | 2016-04-29 |
| Date of Report | 2014-03-20 |
| Date Mfgr Received | 2014-03-20 |
| Date Added to Maude | 2016-04-29 |
| 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 FLO-TECH 22X20 9153652318 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2016-04-29 |
| Model Number | FT2220 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-04-29 |