MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for CAREX TRANSPORT CHAIR FGA22600 0000 manufactured by Eurocare - Shanghai Maxcare Medical Device Co Ltd.
[60844676]
Consumer received a transport chair a month ago and while in the dining room at their assisted living residence, the end user scooted his chair back with his feet and fell backwards and hit his head on the wall. The nurses at the assisted living looked him over and said he was ok. Small cut on top of head. Laminate floor in dining room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2016-00003 |
| MDR Report Key | 6126042 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-03 |
| Date Facility Aware | 2016-11-03 |
| Report Date | 2016-11-23 |
| Date Reported to FDA | 2016-11-23 |
| Date Reported to Mfgr | 2016-11-23 |
| Date Added to Maude | 2016-11-23 |
| 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 CAREGIVERS |
| 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 | INM |
| Date Received | 2016-11-23 |
| Returned To Mfg | 2016-11-21 |
| Model Number | FGA22600 0000 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EUROCARE - SHANGHAI MAXCARE MEDICAL DEVICE CO LTD |
| Manufacturer Address | NO.1 QIANAN RD DIANSHANHU TOWN KUNSHAN CITY, SUZHOU JIANGSU 215345 CH 215345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-23 |