MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for MERIDIAN OPTIMUM COMFORT GEL CUSHION HDC-9B 18X16 manufactured by Gri Medical & Electronic Technology Co., Ltd.
[125904829]
Patient was sitting at the table in a regular chair with her gel cushion and slid off the gel cushion to the floor. Patient sustained right hip fracture and required surgical repair. X-ray done at emergency room confirmed fracture of the right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00055 |
| MDR Report Key | 8031053 |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-20 |
| Date Facility Aware | 2018-10-26 |
| Report Date | 2018-11-01 |
| Date Reported to FDA | 2018-11-01 |
| Date Reported to Mfgr | 2018-11-01 |
| Date Added to Maude | 2018-11-01 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIDIAN OPTIMUM COMFORT GEL CUSHION |
| Generic Name | GEL CUSHION |
| Product Code | IMP |
| Date Received | 2018-11-01 |
| Model Number | HDC-9B 18X16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD |
| Manufacturer Address | 1805 HONGGAO ROAD XIUZHOU INDUSTRY ZONE JIAXING ZHEJIANG, CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-11-01 |