MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-21 for LUMEX EXTRA WIDE CLINICAL CARE RECLINER 587W247 * manufactured by Graham-field Health Products, Inc..
[17492201]
Patient was seated in a cardiac chair-recliner type- when she attempted to stand and got her right leg caught in the chair between the foot rest and the seat cushion. The patient has a left above the knee amputation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042314 |
| MDR Report Key | 830992 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-03-21 |
| Date of Event | 2007-03-02 |
| Date Added to Maude | 2007-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMEX EXTRA WIDE CLINICAL CARE RECLINER |
| Generic Name | CARDIAC CHAIR |
| Product Code | BYN |
| Date Received | 2007-03-21 |
| Model Number | 587W247 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 818336 |
| Manufacturer | GRAHAM-FIELD HEALTH PRODUCTS, INC. |
| Manufacturer Address | 2935 NORTHEAST PARKWAY ATLANTA GA 30360 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2007-03-21 |