MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-20 for CAREX TRANSPORT CHAIR FGA33677 0000 A336-77 manufactured by Eurocare Innovation Co., Ltd..
[78018880]
The left front wheel popped off of the transport chair, and the end-user fell sideways. There is also a screw on the back of the chair that is not centered properly. The end-user went to the emergency room, and they did x-rays, and is okay, but she is bruised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00069 |
| MDR Report Key | 6653543 |
| Date Received | 2017-06-20 |
| Date of Report | 2017-06-20 |
| Date Facility Aware | 2017-05-25 |
| Report Date | 2017-06-20 |
| Date Reported to FDA | 2017-06-20 |
| Date Reported to Mfgr | 2017-06-20 |
| Date Added to Maude | 2017-06-20 |
| 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 |
| 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 | CAREX TRANSPORT CHAIR |
| Generic Name | TRANSPORT CHAIR |
| Product Code | KNN |
| Date Received | 2017-06-20 |
| Model Number | FGA33677 0000 |
| Catalog Number | A336-77 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EUROCARE INNOVATION CO., LTD. |
| Manufacturer Address | NO. 1 QIANAN RD. DIANSHANHU TO KUNSHAN CITY, JIANGSU, CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-20 |