MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for INVACARE MATRXFLOVAIR GENTLE CONTOUR 18 IN X 16 IN 9153653321 ITFG manufactured by Invacare Cleveland Street.
[54314076]
A follow up will be sent if the product or additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[54314077]
The dealer stated the zipper had broken and the seam was coming apart. Mother of the end user stated the end user was sliding on the damaged cushion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219590-2016-00123 |
| MDR Report Key | 5916868 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-08-31 |
| 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 CLEVELAND STREET |
| Manufacturer Street | 899 CLEVELAND 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 MATRXFLOVAIR GENTLE CONTOUR 18 IN X 16 IN 9153653321 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | KNN |
| Date Received | 2016-08-31 |
| Model Number | ITFG |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CLEVELAND STREET |
| Manufacturer Address | 899 CLEVELAND STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-31 |