MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-23 for CUSHION RIGIDIZER 16 IN X 18 IN 9153653338 UNKNOWN manufactured by Unknown.
[41157063]
Should additional information become available for the patient a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[41157064]
Dealer is stating that shell is cracked on the matrx back cushion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2016-00841 |
| MDR Report Key | 5520534 |
| Date Received | 2016-03-23 |
| Date of Report | 2016-03-03 |
| Date Mfgr Received | 2016-03-03 |
| Date Added to Maude | 2016-03-23 |
| 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 | CUSHION RIGIDIZER 16 IN X 18 IN 9153653338 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2016-03-23 |
| 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 | 2016-03-23 |