MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-03 for INVACARE MATRX FLOVAIR GENTLE CONTOUR 18X18 ITFG manufactured by Invacare Cleveland Street.
[5557799]
Dealer reported that the foam in an itfg "in touch" cushion is compressed in the middle rear and the overlay is sliding off the foam causing the zipper to break. Bladder inside is not broken. The end user is allegedly getting a pressure sore on their lower right buttock, stage 2 pressure ulcer. End user reported that this is the first pressure sore and he has been in and out of hospital with the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219590-2015-00051 |
| MDR Report Key | 4562228 |
| Report Source | 08 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-03-02 |
| Date Mfgr Received | 2015-03-02 |
| Date Added to Maude | 2015-03-03 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 3 |
| Brand Name | INVACARE MATRX FLOVAIR GENTLE CONTOUR 18X18 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2015-03-03 |
| 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 | 1. Other | 2015-03-03 |